A Phase 3 interventional study of Itopride Hydrochloride 150 mg extended release tablets and Itopride Hydrochloride 50 mg film coated tablets in Functional Dyspepsia, sponsored by Abbott. Completed at 19 sites in 5 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-04-03.
Sponsored by Abbott · Phase 3, Interventional, and Treatment
The study is conducted in patients with functional dyspepsia or chronic gastritis. The purpose of this study is to:
This is a muti-national study, in subjects with functional dyspepsia. The study will screen approximately 700 subjects and include 564 subjects (282 subjects in both arms Test and Active control arm) and the treatment will be given as follows.
387 studies on the registry are indexed under Abdominal Pain; 58 are open to participants now.
This study's enrollment of 564 is above the median of 70 across 290 interventional studies indexed under Abdominal Pain.
Browse Abdominal Pain studies →Abbott is the lead sponsor of 361 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects with functional (non-ulcer) dyspepsia according to Rome IV criteria including postprandial distress syndrome (PDS) and with or without EPS (epigastric pain syndrome) with one or more of the following:
No evidence of organic, systemic, metabolic or structural disease likely to explain symptoms - Subjects who have to undergone physical examination and lab tests (including white-cell and red-cell counts, measurement of fasting blood sugar and liver-function tests), abdominal ultrasonography, and upper GI endoscopy* in order to rule out structural cause for symptoms of FD.
*history of upper GI endoscopy within 6 months prior to enrolment or at screening.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Test group - Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals (preferably the same meal throughout the treatment)
Drug: Itopride Hydrochloride 150 mg extended release tablets
Drug: Itopride Hydrochloride 50 mg film coated tablets
The intervention in the study is in form of test and active control groups- see details below • Test group - Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals (preferably the same meal throughout the treatment) • Active Control group - Itopride Hydrochloride 50 mg film coated tablets 3 times daily before meals
The intervention in the study is in form of test and active control groups- see details below • Test group - Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals (preferably the same meal throughout the treatment) • Active Control group - Itopride Hydrochloride 50 mg film coated tablets 3 times daily before meals
Change in the Overall Severity of Functional Dyspepsia Between Baseline and Week 8, as Measured by the LDQ Severity Score
Change in the overall severity of functional dyspepsia between baseline and week 8, as measured by the Leeds Dyspepsia Questionnaire (LDQ) severity score consisting of 15 questions, where questions 1-8 are used to measure the severity, on a scale of 0 to 5 (0= absence, 1= very mild, 5=very severe). End Result: Maximum severity score is 40, symptom free=0, very mild =1-4, mild=5-8, moderate=9-15, severe is 16-40
Time frame: 8 weeks
Change in the Overall Severity of Functional Dyspepsia Between Baseline and Week 4, as Measured by the LDQ Severity Score
Change in the overall severity of functional dyspepsia between baseline and week 4, as measured by the Leeds Dyspepsia Questionnaire (LDQ) severity score. Change in the overall severity of functional dyspepsia between baseline and week 8, as measured by the Leeds Dyspepsia Questionnaire (LDQ) severity score consisting of 15 questions, where questions 1-8 are used to measure the severity, on a scale of 0 to 5 (0= absence, 1= very mild, 5=very severe). End Result: Maximum severity score is 40, symptom free=0, very mild =1-4, mild=5-8, moderate=9-15, severe is 16-40.
Time frame: 4 weeks
Disease Specific Quality of Life (Nepean Dyspepsia Index NDI) Assessed at Baseline and Week 8 in Terms of Change in % of Functional Ability.
To assess quality of life for the two treatment arms using Disease Specific Quality of Life (Short Form - Nepean Dyspepsia Index SF-NDI) at baseline and end of treatment. The SF-NDI measures dyspepsia's impact on quality of life, with scores ranging from 10-50 (higher = worse). It includes five subscales-tension/anxiety, daily activities, eating/drinking, knowledge/control, and work/study-each with two questions rated on a 5-point Likert scale (1 = not at all, 5 = extremely). Step-1: sum of scores, step-2: converted to %disability, Step-3: convert to %functional ability (100-%disability). Higher score represents higher Quality of Life and lower scores lower Quality of Life.
Time frame: 8 weeks
Change From Baseline of NRS 11 Score for Symptoms (Sensation of Bloating) After 4 Weeks of Treatment.
Change from baseline of NRS 11 score for symptoms (sensation of bloating, early satiety, postprandial fullness, upper abdominal pain or discomfort (epigastric pain, epigastric burning), anorexia (loss of appetite), heartburn, nausea and vomiting) after 4 and 8 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
Time frame: 4 weeks
Change From Baseline of NRS 11 Score for Symptoms (Sensation of Bloating) After 8 Weeks of Treatment.
Participants assigned to Itopride Hydrochloride 150 mg extended release tablets group administered one tablet a day for 8 weeks. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
Time frame: 8 weeks
Change From Baseline of NRS 11 Score for Symptoms (Early Satiety) After 4 Weeks of Treatment.
We have assessed the change from baseline of NRS 11 score for symptoms (Early Satiety) after 4 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
Time frame: 4 weeks
Change From Baseline of NRS 11 Score for Symptoms (Early Satiety) After 8 Weeks of Treatment.
We have assessed the change from baseline of NRS 11 score for symptoms (Early Satiety) after 8 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
Time frame: 8 weeks
Change From Baseline of NRS 11 Score for Symptoms (Postprandial Fullness) After 4 Weeks of Treatment.
We have assessed the change from baseline of NRS 11 score for symptoms (Postprandial Fullness) after 4 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
Time frame: 4 weeks
Change From Baseline of NRS 11 Score for Symptoms (Postprandial Fullness) After 8 Weeks of Treatment.
We have assessed the change from baseline of NRS 11 score for symptoms (postprandial Fullness) after 8 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
Time frame: 8 weeks
Change From Baseline of NRS 11 Score for Symptoms (Upper Abdominal Pain or Discomfort) After 4 Weeks of Treatment.
We have assessed the change from baseline of NRS 11 score for symptoms (Upper Abdominal Pain or Discomfort) after 4 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
Time frame: 4 weeks
Change From Baseline of NRS 11 Score for Symptoms (Upper Abdominal Pain or Discomfort) After 8 Weeks of Treatment.
We have assessed the change from baseline of NRS 11 score for symptoms (Upper Abdominal Pain or Discomfort) after 8 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
Time frame: 8 weeks
Change From Baseline of NRS 11 Score for Symptoms (Anorexia (Loss of Apetite)) After 4 Weeks of Treatment.
We have assessed the change from baseline of NRS 11 score for symptoms (Anorexia (Loss of Apetite)) after 4 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
Time frame: 4 weeks
Change From Baseline of NRS 11 Score for Symptoms (Anorexia (Loss of Apetite)) After 8 Weeks of Treatment.
We have assessed the change from baseline of NRS 11 score for symptoms (Anorexia (Loss of Apetite)) after 8 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
Time frame: 8 weeks
Change From Baseline of NRS 11 Score for Symptoms (Heartburn) After 4 Weeks of Treatment.
We have assessed the change from baseline of NRS 11 score for symptoms (Heartburn) after 4 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
Time frame: 4 weeks
Change From Baseline of NRS 11 Score for Symptoms (Heartburn) After 8 Weeks of Treatment.
We have assessed the change from baseline of NRS 11 score for symptoms (Heartburn) after 8 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
Time frame: 8 weeks
Change From Baseline of NRS 11 Score for Symptoms (Nausea) After 4 Weeks of Treatment.
We have assessed the change from baseline of NRS 11 score for symptoms (Nausea) after 4 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
Time frame: 4 weeks
Change From Baseline of NRS 11 Score for Symptoms (Nausea) After 8 Weeks of Treatment.
We have assessed the change from baseline of NRS 11 score for symptoms (Nausea) after 8 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
Time frame: 8 weeks
Change From Baseline of NRS 11 Score for Symptoms (Vomiting) After 4 Weeks of Treatment.
We have assessed the change from baseline of NRS 11 score for symptoms (Vomiting) after 4 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
Time frame: 4 weeks
Change From Baseline of NRS 11 Score for Symptoms (Vomiting) After 8 Weeks of Treatment.
We have assessed the change from baseline of NRS 11 score for symptoms (Vomiting) after 8 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
Time frame: 8 weeks
Treatment Acceptance by Subjects Using 5-point Likert Scale at the End of the Treatment
Treatment acceptance and ease of use assessed by subjects using 5-point Likert scale (1. Not at all satisfied, 2. Slightly satisfied, 3. Neutral, 4. Very satisfied, 5. Extremely satisfied.)
Time frame: 8 weeks
Evaluation of Safety and Tolerability in Both Treatment Arms
Evaluation of the safety and tolerability of the two treatments by assessing the following safety endpoints: Treatment emergent adverse events (TEAEs) as detected by physical examination, laboratory assessments and vital signs. For each unique treatment, treatment emergent AEs will be summarized per primary standard of care, Highest Level Term by primary Standard of care and per preferred term by highest level term and primary standard of care.
Time frame: 8 weeks
This study enrolled 564 participants at 19 investigation sites across five countries (Armenia, Malaysia, Philippines, Thailand, Vietnam) from 28-Feb-2024 to 28-Feb-2025. Per protocol population (50 mg: N=263, 150 mg: N=261) Full analysis subject samples- 50 mg: N=280, 150 mg: N=277. Safety Subject sample- 50 mg: N=281, 150 mg: N=280
| Milestone | Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals | Itopride Hydrochloride 50 mg Film-coated Tablet |
|---|---|---|
| Started | 282 | 282 |
| Completed | 269 | 274 |
| Not completed | 13 | 8 |
| Withdrew: Withdrawal by subject | 3 | 3 |
| Withdrew: Adverse event | 6 | 2 |
| Withdrew: Lack of efficacy | 0 | 1 |
| Withdrew: Lost to follow-up | 2 | 0 |
| Withdrew: Failure to meet randomization criteria | 2 | 1 |
| Withdrew: Physician decision | 0 | 1 |
Change in the overall severity of functional dyspepsia between baseline and week 8, as measured by the Leeds Dyspepsia Questionnaire (LDQ) severity score consisting of 15 questions, where questions 1-8 are used to measure the severity, on a scale of 0 to 5 (0= absence, 1= very mild, 5=very severe). End Result: Maximum severity score is 40, symptom free=0, very mild =1-4, mild=5-8, moderate=9-15, severe is 16-40
| units on a scale | Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals | Active Control Group - Itopride Hydrochloride 50 mg Film |
|---|---|---|
| Change in the Overall Severity of Functional Dyspepsia Between Baseline and Week 8, as Measured by the LDQ Severity Score | -9.54 (-10.17 to -8.91) | -9.17 (-9.78 to -8.56) |
Change in the overall severity of functional dyspepsia between baseline and week 4, as measured by the Leeds Dyspepsia Questionnaire (LDQ) severity score. Change in the overall severity of functional dyspepsia between baseline and week 8, as measured by the Leeds Dyspepsia Questionnaire (LDQ) severity score consisting of 15 questions, where questions 1-8 are used to measure the severity, on a scale of 0 to 5 (0= absence, 1= very mild, 5=very severe). End Result: Maximum severity score is 40, symptom free=0, very mild =1-4, mild=5-8, moderate=9-15, severe is 16-40.
| units on a scale | Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals | Active Control Group - Itopride Hydrochloride 50 mg Film |
|---|---|---|
| Change in the Overall Severity of Functional Dyspepsia Between Baseline and Week 4, as Measured by the LDQ Severity Score | -6.99 (-7.62 to -6.36) | -6.78 (-7.39 to -6.17) |
To assess quality of life for the two treatment arms using Disease Specific Quality of Life (Short Form - Nepean Dyspepsia Index SF-NDI) at baseline and end of treatment. The SF-NDI measures dyspepsia's impact on quality of life, with scores ranging from 10-50 (higher = worse). It includes five subscales-tension/anxiety, daily activities, eating/drinking, knowledge/control, and work/study-each with two questions rated on a 5-point Likert scale (1 = not at all, 5 = extremely). Step-1: sum of scores, step-2: converted to %disability, Step-3: convert to %functional ability (100-%disability). Higher score represents higher Quality of Life and lower scores lower Quality of Life.
| Percentage of Functional ability | Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals | Active Control Group - Itopride Hydrochloride 50 mg Film |
|---|---|---|
| Baseline | 68.27 ± 19.795 | 67.96 ± 19.651 |
| Week 8 | 90.26 ± 14.281 | 90.29 ± 14.096 |
Change from baseline of NRS 11 score for symptoms (sensation of bloating, early satiety, postprandial fullness, upper abdominal pain or discomfort (epigastric pain, epigastric burning), anorexia (loss of appetite), heartburn, nausea and vomiting) after 4 and 8 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
| units on a scale | Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals | Active Control Group - Itopride Hydrochloride 50 mg Film |
|---|---|---|
| Baseline | 2 ± 2.102 | 1.91 ± 1.918 |
| Week 4 | 0.57 ± 1.212 | 0.46 ± 1.076 |
| Change from Baseline to Week 4 | -1.41 ± 2.013 | -1.43 ± 1.699 |
Participants assigned to Itopride Hydrochloride 150 mg extended release tablets group administered one tablet a day for 8 weeks. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
| units on a scale | Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals | Active Control Group - Itopride Hydrochloride 50 mg Film |
|---|---|---|
| Baseline | 2 ± 2.102 | 1.91 ± 1.918 |
| Week 8 | 0.35 ± 0.966 | 0.37 ± 0.951 |
| Change from Baseline to Week 8 | -1.63 ± 2.003 | -1.54 ± 1.806 |
Treatment acceptance and ease of use assessed by subjects using 5-point Likert scale (1. Not at all satisfied, 2. Slightly satisfied, 3. Neutral, 4. Very satisfied, 5. Extremely satisfied.)
| Units on a scale | Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals | Active Control Group - Itopride Hydrochloride 50 mg Film |
|---|---|---|
| Treatment Acceptance by Subjects Using 5-point Likert Scale at the End of the Treatment | 4.22 ± 0.791 | 3.83 ± 1.045 |
Evaluation of the safety and tolerability of the two treatments by assessing the following safety endpoints: Treatment emergent adverse events (TEAEs) as detected by physical examination, laboratory assessments and vital signs. For each unique treatment, treatment emergent AEs will be summarized per primary standard of care, Highest Level Term by primary Standard of care and per preferred term by highest level term and primary standard of care.
| Participants | Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals | Active Control Group - Itopride Hydrochloride 50 mg Film |
|---|---|---|
| Evaluation of Safety and Tolerability in Both Treatment Arms | 73 | 49 |
We have assessed the change from baseline of NRS 11 score for symptoms (Early Satiety) after 4 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
| units on a scale | Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals | Active Control Group - Itopride Hydrochloride 50 mg Film |
|---|---|---|
| Baseline | 1.74 ± 2.01 | 1.83 ± 2.051 |
| Week 4 | 0.53 ± 1.22 | 0.43 ± 1.138 |
| Change from Baseline to Week 4 | -1.2 ± 1.896 | -1.38 ± 1.867 |
We have assessed the change from baseline of NRS 11 score for symptoms (Early Satiety) after 8 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
| units on a scale | Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals | Active Control Group - Itopride Hydrochloride 50 mg Film |
|---|---|---|
| Baseline | 1.74 ± 2.01 | 1.83 ± 2.051 |
| Week 8 | 0.34 ± 0.995 | 0.33 ± 0.909 |
| Change from baseline to Week 8 | -1.4 ± 1.888 | -1.5 ± 1.881 |
We have assessed the change from baseline of NRS 11 score for symptoms (Postprandial Fullness) after 4 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
| Units on a scale | Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals | Active Control Group - Itopride Hydrochloride 50 mg Film |
|---|---|---|
| Baseline | 2.21 ± 2.155 | 2.35 ± 2.182 |
| Week 4 | 0.58 ± 1.194 | 0.44 ± 1.131 |
| Change from Baseline to Week 4 | -1.61 ± 2.097 | -1.9 ± 1.939 |
We have assessed the change from baseline of NRS 11 score for symptoms (postprandial Fullness) after 8 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
| units on a scale | Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals | Active Control Group - Itopride Hydrochloride 50 mg Film |
|---|---|---|
| Baseline | 2.21 ± 2.155 | 2.35 ± 2.182 |
| Week 8 | 0.38 ± 1.023 | 0.36 ± 0.921 |
| Change from Baseline to Week 8 | -1.81 ± 1.996 | -2 ± 1.973 |
We have assessed the change from baseline of NRS 11 score for symptoms (Upper Abdominal Pain or Discomfort) after 4 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
| units on a scale | Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals | Active Control Group - Itopride Hydrochloride 50 mg Film |
|---|---|---|
| Baseline | 1.96 ± 2.27 | 2.17 ± 2.08 |
| Week 4 | 0.48 ± 1.159 | 0.34 ± 0.804 |
| Change from Baseline to Week 4 | -1.46 ± 2.116 | -1.81 ± 1.917 |
We have assessed the change from baseline of NRS 11 score for symptoms (Upper Abdominal Pain or Discomfort) after 8 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
| units on a scale | Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals | Active Control Group - Itopride Hydrochloride 50 mg Film |
|---|---|---|
| Baseline | 1.96 ± 2.27 | 2.17 ± 2.08 |
| Week 8 | 0.32 ± 0.985 | 0.32 ± 0.885 |
| Change from Baseline to Week 8 | -1.63 ± 2.122 | 0.32 ± 0.985 |
We have assessed the change from baseline of NRS 11 score for symptoms (Anorexia (Loss of Apetite)) after 4 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
| units on a scale | Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals | Active Control Group - Itopride Hydrochloride 50 mg Film |
|---|---|---|
| Baseline | 1.05 ± 1.884 | 0.9 ± 1.755 |
| Week 4 | 0.24 ± 0.793 | 0.16 ± 0.631 |
| Change from Baseline to Week 4 | -0.78 ± 1.567 | -0.72 ± 1.693 |
We have assessed the change from baseline of NRS 11 score for symptoms (Anorexia (Loss of Apetite)) after 8 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
| units on a scale | Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals | Active Control Group - Itopride Hydrochloride 50 mg Film |
|---|---|---|
| Baseline | 1.05 ± 1.884 | 0.9 ± 1.755 |
| Week 8 | 0.19 ± 0.881 | 0.14 ± 0.763 |
| Change from Baseline to Week 8 | -0.83 ± 1.656 | -0.76 ± 1.574 |
We have assessed the change from baseline of NRS 11 score for symptoms (Heartburn) after 4 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
| Units on a scale | Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals | Active Control Group - Itopride Hydrochloride 50 mg Film |
|---|---|---|
| Baseline | 1.64 ± 1.917 | 1.65 ± 1.978 |
| Week 4 | 0.32 ± 0.953 | 0.24 ± 0.632 |
| Change from Baseline to Week 4 | -1.29 ± 1.814 | -1.41 ± 1.883 |
We have assessed the change from baseline of NRS 11 score for symptoms (Heartburn) after 8 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
| Units on a scale | Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals | Active Control Group - Itopride Hydrochloride 50 mg Film |
|---|---|---|
| Baseline | 1.64 ± 1.917 | 1.65 ± 1.978 |
| Week 8 | 0.22 ± 0.763 | 0.2 ± 0.74 |
| Change from Baseline to Week 8 | -1.39 ± 1.733 | -1.44 ± 1.911 |
We have assessed the change from baseline of NRS 11 score for symptoms (Nausea) after 4 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
| Units on a scale | Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals | Active Control Group - Itopride Hydrochloride 50 mg Film |
|---|---|---|
| Baseline | 0.85 ± 1.529 | 1.01 ± 1.604 |
| Week 4 | 0.17 ± 0.588 | 0.14 ± 1.54 |
| Change from Baseline to Week 4 | -0.69 ± 1.498 | -0.84 ± 1.54 |
We have assessed the change from baseline of NRS 11 score for symptoms (Nausea) after 8 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
| Units on a scale | Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals | Active Control Group - Itopride Hydrochloride 50 mg Film |
|---|---|---|
| Baseline | 0.85 ± 1.529 | 1.01 ± 1.604 |
| Week 8 | 0.15 ± 0.581 | 0.13 ± 0.593 |
| Change from Baseline to Week 8 | -0.71 ± 1.452 | -0.87 ± 1.566 |
We have assessed the change from baseline of NRS 11 score for symptoms (Vomiting) after 4 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
| units on a scale | Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals | Active Control Group - Itopride Hydrochloride 50 mg Film |
|---|---|---|
| Baseline | 0.31 ± 1.083 | 0.34 ± 1.222 |
| Week 4 | 0.07 ± 0.396 | 0.07 ± 0.66 |
| Change from Baseline to Week 4 | -0.25 ± 1.125 | -0.27 ± 1.032 |
We have assessed the change from baseline of NRS 11 score for symptoms (Vomiting) after 8 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
| Units on a scale | Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals | Active Control Group - Itopride Hydrochloride 50 mg Film |
|---|---|---|
| Baseline | 0.31 ± 1.083 | 0.34 ± 1.222 |
| Week 8 | 0.03 ± 0.304 | 0.03 ± 0.287 |
| Change from Baseline to Week 8 | -0.3 ± 1.144 | -0.31 ± 1.149 |
Collected over 8 weeks. Non-serious events are listed at a 0.40% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals | 0/280 (0%) | 0/280 (0%) | 73/280 (26.1%) |
| Active Control Group - Itopride Hydrochloride 50 mg Film | 0/281 (0%) | 2/281 (0.7%) | 49/281 (17.4%) |
| Event | Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals | Active Control Group - Itopride Hydrochloride 50 mg Film |
|---|---|---|
| Urinary tract infectionInfections and infestations | 0/280 | 1/281 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/280 | 1/281 |
| Event | Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals | Active Control Group - Itopride Hydrochloride 50 mg Film |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 16/280 | 10/281 |
| DizzinessNervous system disorders | 8/280 | 3/281 |
| HeadacheNervous system disorders | 6/280 | 7/281 |
| Abdominal painGastrointestinal disorders | 5/280 | 1/281 |
| NauseaGastrointestinal disorders | 5/280 | 2/281 |
| Abdominal pain upperGastrointestinal disorders | 3/280 | 1/281 |
| InfluenzaInfections and infestations | 3/280 | 1/281 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 3/280 | 1/281 |
| HypertensionVascular disorders | 3/280 | 0/281 |
| NasopharyngitisGastrointestinal disorders | 2/280 | 3/281 |
| Age, Categorical(Participants) | Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals | Active Control Group - Itopride Hydrochloride 50 mg Film Coated Tablets | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 261 | 265 | 526 |
| >=65 years | 21 | 17 | 38 |
| Sex: Female, Male(Participants) | Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals | Active Control Group - Itopride Hydrochloride 50 mg Film Coated Tablets | Total |
|---|---|---|---|
| Female | 215 | 192 | 407 |
| Male | 67 | 90 | 157 |
| Race (NIH/OMB)(Participants) | Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals | Active Control Group - Itopride Hydrochloride 50 mg Film Coated Tablets | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 175 | 178 | 353 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 107 | 104 | 211 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Itopride hydrochloride