A Phase 2 interventional study of X842 and X842 Dummy in Erosive Esophagitis, sponsored by Cinclus Pharma Holding AB. Completed at 42 sites in 8 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Cinclus Pharma Holding AB · Phase 2, Interventional, and Treatment
This study will be conducted in patients with erosive esophagitis due to gastro-esophageal reflux disease (GERD) Los Angeles (LA) grades C or D, and in patients with at least partial symptom response but still endoscopically unhealed (LA grades A or B) after 8 weeks history of standard treatment healing course with PPI, designed to support dose selection for Phase 3 and to investigate safety, tolerability, and healing rates after 4 weeks treatment of X842 or Lansoprazole, and symptom pattern during subsequent 4 weeks treatment with Lansoprazole.
This is a randomized, double-blind, active comparator-controlled study with a parallel-group design including four arms with X842 and one arm with Lansoprazole.
Randomization to one of the treatments with X842 twice daily (BID) 25 mg, 50 mg, 75 mg, 100 mg, or Lansoprazole 30 mg once daily (QD) will be based on a 1:1:1:1:1 scheme.
The duration of each patient's participation in the study, including screening, blind treatment period, and open-label treatment period will be approximately 60 days. The patients will be randomized for 4 weeks of double-blind treatment and will be provided with investigational medicinal product for 35 days.
All patients will have an endoscopic evaluation after 4 weeks of treatment. Following the endoscopic evaluation, all patients will receive subsequent 4 weeks of open-label treatment with Lansoprazole. Repeated symptom evaluation to detect symptom patterns will be assessed during this period.
123 studies on the registry are indexed under Esophagitis; 15 are open to participants now.
This study's enrollment of 248 is above the median of 96 across 99 interventional studies indexed under Esophagitis.
Browse Esophagitis studies →Cinclus Pharma Holding AB is the lead sponsor of 9 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.
Gastro-esophageal reflux disease with endoscopically confirmed esophagitis:
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
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.
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.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
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.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
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.
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.
Patients will receive 2 tablets (X842 25mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 25 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients will receive 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
Drug: X842 · Drug: X842 Dummy · Drug: Lansoprazole · Drug: Lansoprazole Dummy
Patients will receive 2 tablets (X842 50 mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients will receive 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
Drug: X842 · Drug: X842 Dummy · Drug: Lansoprazole · Drug: Lansoprazole Dummy
Patients will receive 2 tablets (X842 50 mg + X842 25 mg) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg + X842 25 mg) in the evening during 4-week double-blind treatment. Thereafter, patients will receive 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
Drug: X842 · Drug: Lansoprazole · Drug: Lansoprazole Dummy
Patients will receive 2 tablets (X842 50 mg×2) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg×2) in the evening during 4-week double-blind treatment. Thereafter, patients will receive 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
Drug: X842 · Drug: Lansoprazole · Drug: Lansoprazole Dummy
Patients will receive 2 tablets (X842 dummy×2) and 1 capsule (Lansoprazole 30 mg) in the morning, and 2 tablets (X842 dummy×2) in the evening during 4-week double-blind treatment. Thereafter, patients will receive 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
Drug: X842 Dummy · Drug: Lansoprazole
Patients will receive X842 tablets.
Patients will receive matching placebo tablets for X842.
Patients will receive Lansoprazole capsule.
Patients will receive matching placebo capsules for Lansoprazole.
Number of Patients With Esophageal Mucosa Healing
The healing of erosive esophagitis due to gastro-esophageal reflux disease (GERD) was assessed. It supported the dose selection X842,through the assessment of healing of erosive esophagitis due to GERD based on endoscopic assessment after 4 weeks of treatment. The dose that would lead to having 85% of the patients have esophageal mucosa healing after 4 weeks of treatment. Following the endoscopic evaluation, all patients received subsequent 4 weeks of open-label treatment with lansoprazole. Repeated symptom evaluation was assessed during this period to detect the symptom pattern. Endoscopy evaluation at 4 weeks was based on the level and duration of acid control achieved with X842. Symptom evaluation was assessed using the validated patient-reported outcome (PRO) QOLRAD (Heartburn version) and patient diaries (RESQ-eDiary).
Time frame: Week 4
Number of Patients With Adverse Events (AEs)
The safety and tolerability of the four dose levels of X842 and Lansoprazole were evaluated, where Lansoprazole served as the active comparator. Here TEAE- Treatment-emergent adverse event, ADR- Adverse drug reaction, SAE- Serious adverse event, and AESI- Adverse events of special interest.
Time frame: From Screening (Day -7 to Day 0) until Week 8
Percentage of Heartburn-Free 24-hour Days
Heartburn-free in a 24-hour day was a day where patient reported having no burning feeling or pain behind breast or in center of upper stomach for both morning and evening. Percentage of heartburn-free 24-hour days based on eDiary(Reflux Symptom Questionnaire electronic Diary: RESQ-eDiary) was evaluated. Reflux-related symptom pattern was evaluated during initial 4 weeks of treatment with four dose levels of X842 and with Lansoprazole, and symptom pattern during subsequent additional 4 weeks Lansoprazole treatment in open-label. Modified RESQ-eDiary was validated self-reported questionnaire electronic symptom diary. mRESQ-eD has 3 domains \[i.e. Heartburn (min-max: 0-10), Other GERD signs/symptoms (min-max:0-15) and Regurgitations/Reflux (min-max: 0-8)\]. Endoscopy followed by lansoprazole administration and symptom evaluation using PRO QOLRAD (Heartburn version) and patient diaries assessed acid control achieved with X842 at 4 weeks.
Time frame: Weeks 1 and 8
Percentage at Most-mild Heartburn 24-hour Days
Heartburn with at most mild symptoms in a 24-hour day was defined as a day where the patient reported having either no symptoms, very mild symptoms, or mild burning feeling or pain behind the breast or in the center of the upper stomach (score between 0-2) for both morning and evening. Heartburn assessed the severity as per the following scores (0=Did not have, 1=Very mild, 2=Mild, 3=Moderate, 4=Moderately severe, 5=Severe). Here higher scores represent the worst outcome, whereas lower scores represent the better outcome. After endoscopic evaluation, patients received lansoprazole, and symptom evaluation was conducted to detect patterns. Endoscopy evaluation at 4 weeks was based on the level and duration of acid control achieved with X842. Symptom evaluation involved the use of validated PRO QOLRAD (Heartburn version) and patient diaries.
Time frame: Weeks 1 and 8
Investigator Assessment of Symptoms by Frequency and Severity
Investigator assessed severity and frequency of patients' heartburn, regurgitation, and dysphagia in 7 days. Assessment included both severity grade (for severity, items were coded: none, mild, moderate, severe where none represented no complaints, severe represented incapacitating symptoms) and frequency (for frequency, a 7-graded Likert scale was used, ranging from none to all of time) of symptoms. Symptoms were scored as follows: none (no complaints), mild (aware of symptom, but easily tolerated), moderate (discomforting symptom, sufficient to cause interference with normal daily activities and/or sleep), severe (incapacitating symptom, with inability to perform normal daily activities and/or sleep). Following endoscopic evaluation, patients received lansoprazole and underwent symptom evaluation using validated PRO QOLRAD (Heartburn version) and patient diaries.Here, for frequency- All of the time and None of the time, and for symptoms- none and severe data has been presented.
Time frame: Weeks 1 and 8
Change From Baseline in Quality of Life in Reflux and Dyspepsia (QOLRAD) Score
Reflux-related symptom pattern was evaluated during initial 4 weeks of treatment with 4 dose levels of X842 and with Lansoprazole, and symptom pattern during subsequent additional 4 weeks of open-label treatment with Lansoprazole. Heartburn version of QOLRAD is a disease-specific instrument containing 25 questions addressing concerns associated with gastrointestinal symptoms. Questions were rated on a seven-grade (1-7) Likert scale, where a score of 1 represented low quality of life, and as score increased, the patient's condition was considered better. Questions were categorized into 5 domains: emotional distress, sleep disturbance, vitality, food/drink problems, and physical/social functioning. The score in each domain was calculated as the mean of all items in that domain. The score ranges from 1 to 175, higher scores mean a better outcome. After endoscopic evaluation, patients received lansoprazole and underwent symptom evaluation using validated PRO QOLRAD and patient diaries.
Time frame: Baseline, Weeks 1, and 8
This study was conducted at 36 centers which included 248 patients across 08 countries. The trial began on 11 Aug 2021 (first patient enrolled) and was completed on 01 Sep 2022 (Last patient completed).
| Milestone | X842 25 mg BID | X842 50 mg BID | X842 75 mg BID | X842 100 mg BID | Lansoprazole |
|---|---|---|---|---|---|
| Started | 51 | 48 | 52 | 47 | 50 |
| Completed | 45 | 45 | 50 | 41 | 47 |
| Not completed | 6 | 3 | 2 | 6 | 3 |
| Withdrew: Adverse event | 0 | 0 | 0 | 1 | 1 |
| Withdrew: Protocol violation | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 5 | 2 | 2 | 4 | 2 |
| Withdrew: Randomized by mistake | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Other | 1 | 0 | 0 | 0 | 0 |
The healing of erosive esophagitis due to gastro-esophageal reflux disease (GERD) was assessed. It supported the dose selection X842,through the assessment of healing of erosive esophagitis due to GERD based on endoscopic assessment after 4 weeks of treatment. The dose that would lead to having 85% of the patients have esophageal mucosa healing after 4 weeks of treatment. Following the endoscopic evaluation, all patients received subsequent 4 weeks of open-label treatment with lansoprazole. Repeated symptom evaluation was assessed during this period to detect the symptom pattern. Endoscopy evaluation at 4 weeks was based on the level and duration of acid control achieved with X842. Symptom evaluation was assessed using the validated patient-reported outcome (PRO) QOLRAD (Heartburn version) and patient diaries (RESQ-eDiary).
| Participants | X842 25 mg BID | X842 50 mg BID | X842 75 mg BID | X842 100 mg BID | Lansoprazole |
|---|---|---|---|---|---|
| Number of Patients With Esophageal Mucosa Healing | 28 | 28 | 32 | 18 | 20 |
The safety and tolerability of the four dose levels of X842 and Lansoprazole were evaluated, where Lansoprazole served as the active comparator. Here TEAE- Treatment-emergent adverse event, ADR- Adverse drug reaction, SAE- Serious adverse event, and AESI- Adverse events of special interest.
| Participants | X842 25 mg BID | X842 50 mg BID | X842 75 mg BID | X842 100 mg BID | Lansoprazole |
|---|---|---|---|---|---|
| Any AE | 15 | 10 | 12 | 11 | 10 |
| Any TEAE | 14 | 10 | 12 | 11 | 10 |
| Any severe TEAE | 1 | 0 | 0 | 0 | 0 |
| Any treatment related TEAE (ADR) | 4 | 2 | 0 | 2 | 2 |
| Any TEAE leading to study discontinuation | 1 | 0 | 0 | 1 | 0 |
| Any SAE | 1 | 0 | 1 | 0 | 0 |
| Any Serious TEAE | 1 | 0 | 1 | 0 | 0 |
| Any treatment emergent AESI | 0 | 0 | 0 | 0 | 0 |
Heartburn-free in a 24-hour day was a day where patient reported having no burning feeling or pain behind breast or in center of upper stomach for both morning and evening. Percentage of heartburn-free 24-hour days based on eDiary(Reflux Symptom Questionnaire electronic Diary: RESQ-eDiary) was evaluated. Reflux-related symptom pattern was evaluated during initial 4 weeks of treatment with four dose levels of X842 and with Lansoprazole, and symptom pattern during subsequent additional 4 weeks Lansoprazole treatment in open-label. Modified RESQ-eDiary was validated self-reported questionnaire electronic symptom diary. mRESQ-eD has 3 domains \[i.e. Heartburn (min-max: 0-10), Other GERD signs/symptoms (min-max:0-15) and Regurgitations/Reflux (min-max: 0-8)\]. Endoscopy followed by lansoprazole administration and symptom evaluation using PRO QOLRAD (Heartburn version) and patient diaries assessed acid control achieved with X842 at 4 weeks.
| Percentage of days | X842 25 mg BID | X842 50 mg BID | X842 75 mg BID | X842 100 mg BID | Lansoprazole |
|---|---|---|---|---|---|
| Week 1 | 27.0 ± 5.80 | 25.1 ± 5.91 | 29.2 ± 5.56 | 26.1 ± 5.86 | 19.1 ± 5.68 |
| Week 8 | 82.4 ± 6.59 | 73.8 ± 6.51 | 78.6 ± 6.19 | 72.2 ± 6.78 | 59.2 ± 6.48 |
Heartburn with at most mild symptoms in a 24-hour day was defined as a day where the patient reported having either no symptoms, very mild symptoms, or mild burning feeling or pain behind the breast or in the center of the upper stomach (score between 0-2) for both morning and evening. Heartburn assessed the severity as per the following scores (0=Did not have, 1=Very mild, 2=Mild, 3=Moderate, 4=Moderately severe, 5=Severe). Here higher scores represent the worst outcome, whereas lower scores represent the better outcome. After endoscopic evaluation, patients received lansoprazole, and symptom evaluation was conducted to detect patterns. Endoscopy evaluation at 4 weeks was based on the level and duration of acid control achieved with X842. Symptom evaluation involved the use of validated PRO QOLRAD (Heartburn version) and patient diaries.
| Percentage of days | X842 25 mg BID | X842 50 mg BID | X842 75 mg BID | X842 100 mg BID | Lansoprazole |
|---|---|---|---|---|---|
| Week 1 | 75.3 ± 3.78 | 67.9 ± 3.85 | 79.4 ± 3.62 | 69.7 ± 3.81 | 63.1 ± 3.70 |
| Week 8 | 98.5 ± 4.34 | 96.5 ± 4.27 | 95.8 ± 4.08 | 97.1 ± 4.46 | 92.2 ± 4.26 |
Investigator assessed severity and frequency of patients' heartburn, regurgitation, and dysphagia in 7 days. Assessment included both severity grade (for severity, items were coded: none, mild, moderate, severe where none represented no complaints, severe represented incapacitating symptoms) and frequency (for frequency, a 7-graded Likert scale was used, ranging from none to all of time) of symptoms. Symptoms were scored as follows: none (no complaints), mild (aware of symptom, but easily tolerated), moderate (discomforting symptom, sufficient to cause interference with normal daily activities and/or sleep), severe (incapacitating symptom, with inability to perform normal daily activities and/or sleep). Following endoscopic evaluation, patients received lansoprazole and underwent symptom evaluation using validated PRO QOLRAD (Heartburn version) and patient diaries.Here, for frequency- All of the time and None of the time, and for symptoms- none and severe data has been presented.
| Participants | X842 25 mg BID | X842 50 mg BID | X842 75 mg BID | X842 100 mg BID | Lansoprazole |
|---|---|---|---|---|---|
| Week 1 (Dysphagia): Frequency- All of the time | 0 | 2 | 0 | 1 | 0 |
| Week 1 (Dysphagia): Frequency- None of the time | 14 | 10 | 13 | 13 | 11 |
| Week 8 (Dysphagia): Frequency- All of the time | 0 | 0 | 0 | 1 | 0 |
| Week 8 (Dysphagia): Frequency- None of the time | 42 | 37 | 43 | 34 | 40 |
| Week 1 (Heartburn): Frequency- All of the time | 4 | 0 | 3 | 3 | 3 |
| Week 1 (Heartburn): Frequency- None of the time | 1 | 0 | 4 | 4 | 1 |
| Week 8 (Heartburn): Frequency- All of the time | 0 | 0 | 0 | 0 | 0 |
| Week 8 (Heartburn): Frequency- None of the time | 38 | 37 | 43 | 33 | 36 |
| Week 1 (Regurgitation/Reflux): Frequency- All of the time | 1 | 0 | 2 | 1 | 0 |
| Week 1 (Regurgitation/Reflux): Frequency- None of the time | 1 | 2 | 4 | 4 | 3 |
| Week 8 (Regurgitation/Reflux): Frequency- All of the time | 0 | 0 | 0 | 1 | 0 |
| Week 8 (Regurgitation/Reflux): Frequency- None of the time | 41 | 36 | 41 | 32 | 39 |
| Week 1 (Dysphagia): Symptom- None | 14 | 12 | 13 | 15 | 12 |
| Week 1 (Dysphagia): Symptom- Severe | 1 | 2 | 2 | 2 | 1 |
| Week 8 (Dysphagia): Symptom- None | 42 | 37 | 43 | 35 | 41 |
| Week 8 (Dysphagia): Symptom- Severe | 0 | 0 | 0 | 0 | 0 |
| Week 1 (Heartburn): Symptom- None | 1 | 0 | 4 | 5 | 1 |
| Week 1 (Heartburn): Symptom- Severe | 5 | 1 | 4 | 2 | 3 |
| Week 8 (Heartburn): Symptom- None | 38 | 37 | 44 | 33 | 38 |
| Week 8 (Heartburn): Symptom- Severe | 1 | 0 | 1 | 0 | 0 |
| Week 1 (Regurgitation/Reflux): Symptom- None | 1 | 3 | 6 | 5 | 3 |
| Week 1 (Regurgitation/Reflux): Symptom- Severe | 3 | 3 | 5 | 4 | 2 |
| Week 8 (Regurgitation/Reflux): Symptom- None | 41 | 36 | 41 | 33 | 41 |
| Week 8 (Regurgitation/Reflux): Symptom- Severe | 0 | 0 | 0 | 0 | 1 |
Reflux-related symptom pattern was evaluated during initial 4 weeks of treatment with 4 dose levels of X842 and with Lansoprazole, and symptom pattern during subsequent additional 4 weeks of open-label treatment with Lansoprazole. Heartburn version of QOLRAD is a disease-specific instrument containing 25 questions addressing concerns associated with gastrointestinal symptoms. Questions were rated on a seven-grade (1-7) Likert scale, where a score of 1 represented low quality of life, and as score increased, the patient's condition was considered better. Questions were categorized into 5 domains: emotional distress, sleep disturbance, vitality, food/drink problems, and physical/social functioning. The score in each domain was calculated as the mean of all items in that domain. The score ranges from 1 to 175, higher scores mean a better outcome. After endoscopic evaluation, patients received lansoprazole and underwent symptom evaluation using validated PRO QOLRAD and patient diaries.
| Scores on scale | X842 25 mg BID | X842 50 mg BID | X842 75 mg BID | X842 100 mg BID | Lansoprazole |
|---|---|---|---|---|---|
| Week 1: Emotional Distress Score | 1.69 ± 0.247 | 1.55 ± 0.251 | 1.14 ± 0.233 | 1.54 ± 0.255 | 1.34 ± 0.241 |
| Week 8: Emotional Distress Score | 2.76 ± 0.265 | 2.51 ± 0.275 | 1.84 ± 0.253 | 2.00 ± 0.278 | 2.19 ± 0.269 |
| Week 1: Food/Drink Problems Score | 1.84 ± 0.229 | 1.62 ± 0.232 | 1.32 ± 0.217 | 1.65 ± 0.238 | 1.40 ± 0.223 |
| Week 8: Food/Drink Problems Score | 3.08 ± 0.249 | 2.97 ± 0.259 | 2.34 ± 0.240 | 2.28 ± 0.264 | 2.56 ± 0.256 |
| Week 1: Physical/Social Functioning Score | 1.26 ± 0.247 | 1.32 ± 0.252 | 1.02 ± 0.233 | 1.19 ± 0.255 | 0.97 ± 0.241 |
| Week 8: Physical/Social Functioning Score | 2.06 ± 0.262 | 2.26 ± 0.271 | 1.57 ± 0.249 | 1.60 ± 0.274 | 1.71 ± 0.265 |
| Week 1: Sleep Disturbance Score | 1.60 ± 0.250 | 1.45 ± 0.255 | 1.08 ± 0.236 | 1.49 ± 0.258 | 1.54 ± 0.244 |
| Week 8: Sleep Disturbance Score | 2.78 ± 0.266 | 2.48 ± 0.276 | 1.89 ± 0.254 | 1.91 ± 0.279 | 2.37 ± 0.270 |
| Week 1:Vitality Score | 1.55 ± 0.237 | 1.51 ± 0.240 | 1.42 ± 0.224 | 1.50 ± 0.246 | 1.21 ± 0.231 |
| Week 8: Vitality Score | 2.84 ± 0.257 | 2.79 ± 0.268 | 2.25 ± 0.247 | 2.21 ± 0.272 | 2.19 ± 0.264 |
Collected over From Screening (Day -7 to Day 0) until Week 8. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| X842 25 mg BID | 0/51 (0%) | 1/51 (2%) | 14/51 (27.5%) |
| X842 50 mg BID | 0/48 (0%) | 0/48 (0%) | 10/48 (20.8%) |
| X842 75 mg BID | 0/52 (0%) | 1/52 (1.9%) | 12/52 (23.1%) |
| X842 100 mg BID | 0/47 (0%) | 0/47 (0%) | 11/47 (23.4%) |
| Lansoprazole | 0/50 (0%) | 0/50 (0%) | 10/50 (20%) |
| Event | X842 25 mg BID | X842 50 mg BID | X842 75 mg BID | X842 100 mg BID | Lansoprazole |
|---|---|---|---|---|---|
| CholecystitisHepatobiliary disorders | 1/51 | 0/48 | 0/52 | 0/47 | 0/50 |
| LaryngospasmRespiratory, thoracic and mediastinal disorders | 0/51 | 0/48 | 1/52 | 0/47 | 0/50 |
| Event | X842 25 mg BID | X842 50 mg BID | X842 75 mg BID | X842 100 mg BID | Lansoprazole |
|---|---|---|---|---|---|
| COVID-19Infections and infestations | 1/51 | 2/48 | 1/52 | 4/47 | 2/50 |
| NauseaGastrointestinal disorders | 1/51 | 0/48 | 0/52 | 0/47 | 4/50 |
| HeadacheNervous system disorders | 1/51 | 3/48 | 1/52 | 1/47 | 1/50 |
| RegurgitationGastrointestinal disorders | 0/51 | 2/48 | 0/52 | 2/47 | 0/50 |
| EructationGastrointestinal disorders | 0/51 | 0/48 | 0/52 | 2/47 | 0/50 |
| NasopharyngitisInfections and infestations | 1/51 | 2/48 | 0/52 | 1/47 | 0/50 |
| ConstipationGastrointestinal disorders | 2/51 | 1/48 | 2/52 | 0/47 | 0/50 |
| DiarrhoeaGastrointestinal disorders | 2/51 | 0/48 | 1/52 | 0/47 | 0/50 |
| DysphagiaGastrointestinal disorders | 1/51 | 1/48 | 0/52 | 1/47 | 0/50 |
| Oesophageal painGastrointestinal disorders | 0/51 | 1/48 | 0/52 | 1/47 | 0/50 |
The full analysis set (FAS) consisted of all patients who have been randomized and received at least 1 dose of study drug.
| Age, Continuous(Years) | X842 25 mg BID | X842 50 mg BID | X842 75 mg BID | X842 100 mg BID | Lansoprazole | Total |
|---|---|---|---|---|---|---|
| Mean | 48.7 ± 15.99 | 45.3 ± 14.11 | 48.7 ± 14.05 | 54.8 ± 13.26 | 49.1 ± 15.41 | 49.3 ± 14.81 |
| Sex: Female, Male(Participants) | X842 25 mg BID | X842 50 mg BID | X842 75 mg BID | X842 100 mg BID | Lansoprazole | Total |
|---|---|---|---|---|---|---|
| Female | 18 | 19 | 22 | 17 | 20 | 96 |
| Male | 33 | 29 | 30 | 30 | 30 | 152 |
| Ethnicity (NIH/OMB)(Participants) | X842 25 mg BID | X842 50 mg BID | X842 75 mg BID | X842 100 mg BID | Lansoprazole | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 1 | 0 | 0 | 3 |
| Not Hispanic or Latino | 49 | 48 | 50 | 47 | 48 | 242 |
| Unknown or Not Reported | 0 | 0 | 1 | 0 | 2 | 3 |
| Race (NIH/OMB)(Participants) | X842 25 mg BID | X842 50 mg BID | X842 75 mg BID | X842 100 mg BID | Lansoprazole | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 | 0 |
| White | 50 | 48 | 52 | 47 | 50 | 247 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 0 | 0 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Aug 2021 to primary completion in Sep 2022, 12 months.
Results were first posted in Nov 2023, 1 year 2 months after primary completion.
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Studies of the drug tested here: Linaprazan glurate
Cinclus Pharma Holding AB