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CompletedNCT03793556Updated Mar 31, 2020Results posted

Evaluation of GERDOFF Efficacy in Combination With Proton Pump Inhibitor

An interventional study of GERDOFF® + Omeprazole and Omeprazole in Gastro-oesophageal Reflux Disease, sponsored by SOFAR S.p.A.. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-31.

Sponsored by SOFAR S.p.A. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled May 2017, registered Dec 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The aim of the present study was to evaluate the effect of a 6-weeks treatment of a CE-marked combination oral formulation of hyaluronic acid with chondroitin sulphate and aluminium hydroxide (GERDOFF®), in addition to proton pump inhibitors (PPI) at the standard dose, versus PPI only, in patients with first diagnosed clinical presentation of extra-esophageal GERD symptoms.

The investigators verified the reduction of symptoms frequency, using a Likert questionnaire, and severity, using the Reflux Symptom Index (RSI) questionnaire, to evaluate the proportion of Responders and Non-Responder patients in these two groups after 6 weeks of treatment, compared to baseline. Moreover investigators evaluated the persistence of effects of GERDOFF® + PPI treatment on extraesophageal symptoms, after a 12-weeks follow up, only in responder patients.

Read the detailed description

Cough, hoarseness, prolonged voice lowering, and vocal timbre modification, without any documentable cause, are considered as minor disorders for which patients do not receive adequate attention. These disorders may represent extra-esophageal manifestations of gastro-oesophagea reflux. Accurate diagnosis and gastro-oesophageal reflux therapy have been proved as useful to improve patients' quality of life.

The aim of the present study was to evaluate, in first diagnosed patients presenting with upper symptoms associated with GERD, the effect of a 6-week treatment with a combination based on CS, HA and aluminium hydroxide (Gerdoff®), co-administered with a treatment with PPIs, compared to treatment with PPIs as monotherapy, i.e. to verify, in patients treated with the combination of the two products, the reduction in symptoms frequency by means of a Likert questionnaire and the severity of upper symptoms by means of the Reflux Symptom Index (RSI) questionnaire, and to collect safety data. After 6 weeks of treatment, patients included in the two groups were then classified as responders or non-responders. Responder patients were defined as those patients that, at the 6th week of treatment, reached a RSI score decreased for at least 50% compared to baseline and an absolute value \< 13.

Furthermore, the maintenance of the effect of treatment on the extra-oesophageal symptoms was evaluated after a period of follow-up lasting 12 weeks, which could be entered only by responder patients randomised in the Gerdoff®-PPI arm. Patients included in the follow-up period were randomised to receive Gerdoff® or no treatment (control group). Safety data were also evaluated in the group of patients that continued in the follow-up period.

02

Conditions studied

  • Gastro-oesophageal Reflux Disease
03

In context

Gastroesophageal Reflux

1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.

This study's enrollment of 72 is close to the median of 68 across 796 interventional studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

SOFAR S.p.A. is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  1. Male or female subjects aged ≥ 18 years;
  2. First diagnosis of GERD with upper symptoms, made on a clinical basis and confirmed by an ENT and/or confirmed by a Gastroenterologist using a RSI questionnaire;
  3. Presence of extra-oesophageal symptoms associated with GERD;
  4. RSI score ≥ 20;
  5. Patients not pre-treated with PPIs, even for problems different from GERD, and/or with medical devices and/or similar products (e.g. antacid alginates etc..) in the last 4 weeks;
  6. Cooperative patients, able to understand and adhere to the study procedures;
  7. Patient able to freely give their written to study participation;
  8. Patients that freely gave the consent to management of personal data related to the study.

Exclusion criteria

Exclusion Criteria:

  1. Known infective oesophagitis or oesophagitis due to acid or alkaline substances;
  2. Acute or chronic rhinosinusitis;
  3. Chronic bronchitis;
  4. Known Zollinger-Ellison syndrome, hiatal hernia greater than 3 cm and Barrett oesophagus;
  5. Ongoing neoplasias;
  6. Uncontrolled diabetes;
  7. Patients with impaired liver function;
  8. Patients with rare hereditary problems of galactose intolerance;
  9. Patients that, based on Investigator's opinion, could not take part in the study due to other diseases or concomitant therapies, such as the intake of atazanavir, nelfinavir, clopidogrel, posaconazole and erlotinib (as recommended in the Summary of Product Characteristics of Gerdoff®);
  10. Patients with deficiency of Lapp lactase;
  11. Patients with syndrome of glu-gal malabsorption;
  12. Patients with to omeprazole, substitute benzymidazolic or any of the ;
  13. Patients already in treatment with PPIs or similar products;
  14. Chronic use of drugs that interfere with the salivary secretion (e.g. anti-histamines or inhaled );
  15. Abuse of drug or alcohol;
  16. Inability of the subject to adequately express his/her disturbances;
  17. Patients with planned or ascertained pregnancy or that did not adopt an accepted method;
  18. Lactating patients.
Terms in these criteria, in plain language(5)

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.

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.

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.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    GERDOFF® + omeprazole

    GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).

    Device: GERDOFF® + Omeprazole

  • Active comparator
    Omeprazole

    Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).

    Drug: Omeprazole

Interventions

  • DeviceGERDOFF® + Omeprazole

    GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg + Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).

    Also known as: GERDOFF®

  • DrugOmeprazole

    Omeprazole, 2 capsules 20 mg, once a day before breakfast

    Also known as: Omeprazen

06

What researchers measure

Primary outcomes

  1. Change From Baseline to Visit V4 of the Total Score of RSI Questionnaire

    After 6 weeks of treatment, the changes from baseline in the score of Reflux Symptom Index questionnaire were evaluated to verify the effects of treatments on high symptoms. The RSI questionnaire examines 9 items that are scored from 0 to 5, with a higher score that indicates a higher severity of the symptom (range of total score: 0-45).

    Time frame: In the first visit (baseline) and in the visit 4 (after 6 weeks of treatment)

Secondary outcomes

  1. Total Score of Reflux Symptom Index Questionnaire in All Time-points Assessed

    Total score of the Reflux Symptom Index questionnaire assessed in all time-points. The RSI questionnaire examines 9 items, that are scored from 0 to 5, with a higher score that indicates a higher severity of the symptom (range of total score: 0-45).

    Time frame: In baseline Visit, Visit 2 (after 1 week), Visit 3 (after 3 weeks) and Visit 4 (after 6 weeks of treatment)

  2. Score of Hoarseness or Vocal Problem of the RSI Questionnaire Measured at the Baseline and in the Visit 4

    The Reflux Symptom Index questionnaire examines 9 items, including hoarseness or vocal problem that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

    Time frame: At baseline and in the visit 4, after 6 weeks of treatment

  3. Score of Throat of the RSI Questionnarie Measured at the Baseline and in the Visit 4 of the RSI Questionnaire Score of Throat Clearance

    The Reflux Symptom Index questionnaire examines 9 items, including throat that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

    Time frame: At baseline and in the visit 4, after 6 weeks of treatment

  4. Score of Excess of Mucus in the Throat or Retrosternal Fall of Secretions of the RSI Questionnaire Measured at Baseline and in the Visit 4

    The Reflux Symptom Index questionnaire examines 9 items, including excess of mucus in the throat or retrosternal fall of secretions that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

    Time frame: At baseline and in the visit 4, after 6 weeks of treatment

  5. Score of Difficulty in Swallowing Food, Fluids or Pills of the RSI Questionnaire Measured at Baseline and in the Visit 4

    The Reflux Symptom Index questionnaire examines 9 items, including difficulty in swallowing food, fluids or pills that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

    Time frame: At baseline and in the visit 4, after 6 weeks of treatment

  6. Score of Cough of the RSI Questionnaire Measured at Baseline and in the Visit 4 After the Meal or After Lying

    The Reflux Symptom Index questionnaire examines 9 items, including cough that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

    Time frame: At baseline and in the visit 4, after 6 weeks of treatment

  7. Score of Difficulty in Breathing or Episodes of Choking of the RSI Questionnaire Measured at Baseline and in the Visit 4

    The Reflux Symptom Index questionnaire examines 9 items, including difficulty in breathing or episodes of choking that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

    Time frame: At baseline and in the visit 4, after 6 weeks of treatment

  8. Score of Problematic or Troublesome Cough of the RSI Questionnaire Measured at Baseline and in the Visit 4

    The Reflux Symptom Index questionnaire examines 9 items, including problematic or troublesome cough that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

    Time frame: At baseline and in the visit 4, after 6 weeks of treatment

  9. Score of Sensation of Something Blocked or Mass in the Throat of the RSI Questionnaire Measured at Baseline and in the Visit 4

    The Reflux Symptom Index questionnaire examines 9 items, including sensation of something blocked or mass in the throat that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

    Time frame: At baseline and in the visit 4, after 6 weeks of treatment

  10. Score of Stomach Burning, Thoracic Pain, Poor Digestion of Gastric Acid That Moves Upright of the RSI Questionnaire Measured at Baseline and in the Visit 4

    The Reflux Symptom Index questionnaire examines 9 items, including stomach burning, thoracic pain, poor digestion of gastric acid that moves upright that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

    Time frame: At baseline and in the visit 4, after 6 weeks of treatment

  11. Number of Responders V4

    A responder was defined as a patient who at the 6th week of treatment showed a reduction of at least 50% vs. the baseline and an absolute value \< 13 on the RSI questionnaire.

    Time frame: At visit 4 after 6 weeks of treatment

  12. Number of Responders V6

    Responder patients of Group Gerdoff® + omeprazole were randomly assigned to receive a treatment with Gerdoff®-one tablet three times daily- All patients received a packaging of omeprazole, to be taken only if necessary, at constant dose and according to the indications of the Investigator. The scheduled duration of the follow-up period was 12 weeks. A responder was defined as a patient who at the 6th week of treatment showed a reduction of at least 50% vs. the baseline and an absolute value \< 13 on the RSI questionnaire.

    Time frame: In the Visit 6 at the end of follow-up

  13. Score of Upper Symptoms Using the Likert Scale at Baseline and in the Visit V4

    The Likert scale examines 9 symptoms, to be scored from 0 to 4, with a higher score indication a higher frequency of the symptom (i.e. 0=never, 1=occasionally, 2=sometimes, 3= often, 4=Always); The Likert scale scores of single items are as following: 1. Hoarseness or vocal problem 0 1 2 3 4 2. Throat clearance 0 1 2 3 4 3. Excess of mucus in the throat or retrosternal fall of secretions 0 1 2 3 4 4. Difficulty in swallowing food, fluids or pills 0 1 2 3 4 5. Cough after the meal or after lying 0 1 2 3 4 6. Difficulty in breathing or episodes of choking 0 1 2 3 4 7. Problematic or troublesome cough 0 1 2 3 4 8. Sensation of something blocked or mass in the throat 0 1 2 3 4 9. Stomach burning, thoracic pain, poor digestion of gastric acid that moves upright 0 1 2 3 4. Subscales are summarized to compute a total score (total score ranges from 0-36). The mean values of Likert scale total score are reported.

    Time frame: At baseline and in the visit 4

  14. Presence of Upper Symptoms at Visit 4, Using the RSI Questionnaire

    The Reflux Symptom Index questionnaire examines 9 items, to be scored from 0 to 5, with a higher score indication a higher severity of the symptom (range of total score: 0-45).

    Time frame: At visit 4 after weeks of treatment

  15. Use of Rescue Medication (Omeprazole) During the Treatment

    In the first 6 weeks of treatment, the intake in each treatment group of the rescue medication, allowed or not allowed, was calculated as the frequency of intake of the specific drug and the comparison between groups was performed using the Fisher's exact test.

    Time frame: From baseline to visit 4

  16. Use of Rescue Medication (Omeprazole) During the Follow-up

    During the follow-up, the intake in each treatment group of the rescue medication, allowed or not allowed, was calculated as the frequency of intake of the specific drug.

    Time frame: In the Visit 6 after 12 weeks from baseline

  17. Use of Rescue Medication (Other Than Omeprazole) During Treatment

    During treatment, the intake in each treatment group of the rescue medication, allowed or not allowed, was calculated as the frequency of intake of the specific drug.

    Time frame: From baseline to visit 4

  18. Patients'Satisfaction

    This evaluation was expressed with a semi-quantitative ordinal scale: 0 = low, 1 = discrete, 2 = good, 3 = excellent).

    Time frame: At visit 4 after weeks of treatment

07

Results

Posted Mar 18, 2020

Participant flow

A first specialist visit was performed by an ENT as per clinical practice based on patient's symptoms. Patients sent by the ENT should not have been pre-treated with PPIs and/or medical devices and/or similar products. The diagnosis was confirmed by the Gastroenterologist Investigator who recruited patients.

Participant flow — Overall Study
MilestoneGERDOFF® + OmeprazoleOmeprazole
Started3536
Completed2234
Not completed132
Withdrew: Withdrawal by subject121
Withdrew: Lost to follow-up11

Outcome measures

PrimaryChange From Baseline to Visit V4 of the Total Score of RSI Questionnaire

After 6 weeks of treatment, the changes from baseline in the score of Reflux Symptom Index questionnaire were evaluated to verify the effects of treatments on high symptoms. The RSI questionnaire examines 9 items that are scored from 0 to 5, with a higher score that indicates a higher severity of the symptom (range of total score: 0-45).

Time frame:
In the first visit (baseline) and in the visit 4 (after 6 weeks of treatment)
Reported as:
Mean · Score on a scale
Change From Baseline to Visit V4 of the Total Score of RSI Questionnaire
Score on a scaleGERDOFF® + OmeprazoleOmeprazole
Change From Baseline to Visit V4 of the Total Score of RSI Questionnaire-16.2 ± 7.45-13.7 ± 10.58
Statistical analysis
  • GERDOFF® + Omeprazole vs Omeprazole · Unpaired t test · p = 0.276 · Mean difference (final values): -2.5 · 95% CI -7.03 to 2.04
SecondaryTotal Score of Reflux Symptom Index Questionnaire in All Time-points Assessed

Total score of the Reflux Symptom Index questionnaire assessed in all time-points. The RSI questionnaire examines 9 items, that are scored from 0 to 5, with a higher score that indicates a higher severity of the symptom (range of total score: 0-45).

Time frame:
In baseline Visit, Visit 2 (after 1 week), Visit 3 (after 3 weeks) and Visit 4 (after 6 weeks of treatment)
Reported as:
Mean · score on a scale
Total Score of Reflux Symptom Index Questionnaire in All Time-points Assessed
score on a scaleGERDOFF® + OmeprazoleOmeprazole
Baseline24.2 ± 5.1826.0 ± 4.96
Visit 215.3 ± 7.8619.6 ± 7.20
Visit 312.9 ± 7.7715.3 ± 8.08
Visit 47.9 ± 6.0412.3 ± 8.98
Statistical analysis
  • GERDOFF® + Omeprazole vs Omeprazole · ANOVA · p = 0.0157The ANOVA model examined the entire curve profile.
SecondaryScore of Hoarseness or Vocal Problem of the RSI Questionnaire Measured at the Baseline and in the Visit 4

The Reflux Symptom Index questionnaire examines 9 items, including hoarseness or vocal problem that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

Time frame:
At baseline and in the visit 4, after 6 weeks of treatment
Reported as:
Mean · score on a scale
Score of Hoarseness or Vocal Problem of the RSI Questionnaire Measured at the Baseline and in the Visit 4
score on a scaleGERDOFF® + OmeprazoleOmeprazole
Baseline3.2 ± 1.352.8 ± 1.54
Visit 41.1 ± 1.331.6 ± 1.54
SecondaryScore of Throat of the RSI Questionnarie Measured at the Baseline and in the Visit 4 of the RSI Questionnaire Score of Throat Clearance

The Reflux Symptom Index questionnaire examines 9 items, including throat that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

Time frame:
At baseline and in the visit 4, after 6 weeks of treatment
Reported as:
Mean · score on a scale
Score of Throat of the RSI Questionnarie Measured at the Baseline and in the Visit 4 of the RSI Questionnaire Score of Throat Clearance
score on a scaleGERDOFF® + OmeprazoleOmeprazole
Baseline3.4 ± 1.223.6 ± 1.00
Visit 41.4 ± 1.391.8 ± 1.37
SecondaryScore of Excess of Mucus in the Throat or Retrosternal Fall of Secretions of the RSI Questionnaire Measured at Baseline and in the Visit 4

The Reflux Symptom Index questionnaire examines 9 items, including excess of mucus in the throat or retrosternal fall of secretions that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

Time frame:
At baseline and in the visit 4, after 6 weeks of treatment
Reported as:
Mean · score on a scale
Score of Excess of Mucus in the Throat or Retrosternal Fall of Secretions of the RSI Questionnaire Measured at Baseline and in the Visit 4
score on a scaleGERDOFF® + OmeprazoleOmeprazole
Baseline2.7 ± 1.762.8 ± 1.77
Visit 41.4 ± 1.311.9 ± 1.61
SecondaryScore of Difficulty in Swallowing Food, Fluids or Pills of the RSI Questionnaire Measured at Baseline and in the Visit 4

The Reflux Symptom Index questionnaire examines 9 items, including difficulty in swallowing food, fluids or pills that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

Time frame:
At baseline and in the visit 4, after 6 weeks of treatment
Reported as:
Mean · score on a scale
Score of Difficulty in Swallowing Food, Fluids or Pills of the RSI Questionnaire Measured at Baseline and in the Visit 4
score on a scaleGERDOFF® + OmeprazoleOmeprazole
Baseline1.9 ± 1.661.9 ± 1.84
Visit 40.4 ± 0.710.6 ± 0.94
SecondaryScore of Cough of the RSI Questionnaire Measured at Baseline and in the Visit 4 After the Meal or After Lying

The Reflux Symptom Index questionnaire examines 9 items, including cough that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

Time frame:
At baseline and in the visit 4, after 6 weeks of treatment
Reported as:
Mean · score on a scale
Score of Cough of the RSI Questionnaire Measured at Baseline and in the Visit 4 After the Meal or After Lying
score on a scaleGERDOFF® + OmeprazoleOmeprazole
Baseline2.5 ± 1.763.3 ± 1.44
Visit 40.7 ± 1.011.7 ± 1.47
SecondaryScore of Difficulty in Breathing or Episodes of Choking of the RSI Questionnaire Measured at Baseline and in the Visit 4

The Reflux Symptom Index questionnaire examines 9 items, including difficulty in breathing or episodes of choking that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

Time frame:
At baseline and in the visit 4, after 6 weeks of treatment
Reported as:
Mean · score on a scale
Score of Difficulty in Breathing or Episodes of Choking of the RSI Questionnaire Measured at Baseline and in the Visit 4
score on a scaleGERDOFF® + OmeprazoleOmeprazole
Baseline1.5 ± 1.601.9 ± 1.69
Visit 40.5 ± 1.150.6 ± 0.97
SecondaryScore of Problematic or Troublesome Cough of the RSI Questionnaire Measured at Baseline and in the Visit 4

The Reflux Symptom Index questionnaire examines 9 items, including problematic or troublesome cough that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

Time frame:
At baseline and in the visit 4, after 6 weeks of treatment
Reported as:
Mean · score on a scale
Score of Problematic or Troublesome Cough of the RSI Questionnaire Measured at Baseline and in the Visit 4
score on a scaleGERDOFF® + OmeprazoleOmeprazole
Baseline2.5 ± 1.653.7 ± 1.19
Visit 40.8 ± 1.171.5 ± 1.54
SecondaryScore of Sensation of Something Blocked or Mass in the Throat of the RSI Questionnaire Measured at Baseline and in the Visit 4

The Reflux Symptom Index questionnaire examines 9 items, including sensation of something blocked or mass in the throat that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

Time frame:
At baseline and in the visit 4, after 6 weeks of treatment
Reported as:
Mean · score on a scale
Score of Sensation of Something Blocked or Mass in the Throat of the RSI Questionnaire Measured at Baseline and in the Visit 4
score on a scaleGERDOFF® + OmeprazoleOmeprazole
Baseline3.0 ± 1.522.6 ± 1.75
Visit 40.8 ± 1.081.6 ± 1.59
SecondaryScore of Stomach Burning, Thoracic Pain, Poor Digestion of Gastric Acid That Moves Upright of the RSI Questionnaire Measured at Baseline and in the Visit 4

The Reflux Symptom Index questionnaire examines 9 items, including stomach burning, thoracic pain, poor digestion of gastric acid that moves upright that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

Time frame:
At baseline and in the visit 4, after 6 weeks of treatment
Reported as:
Mean · Score on a scale
Score of Stomach Burning, Thoracic Pain, Poor Digestion of Gastric Acid That Moves Upright of the RSI Questionnaire Measured at Baseline and in the Visit 4
Score on a scaleGERDOFF® + OmeprazoleOmeprazole
Baseline3.4 ± 1.563.5 ± 1.83
Visit 40.8 ± 1.083.5 ± 1.83
SecondaryNumber of Responders V4

A responder was defined as a patient who at the 6th week of treatment showed a reduction of at least 50% vs. the baseline and an absolute value \< 13 on the RSI questionnaire.

Time frame:
At visit 4 after 6 weeks of treatment
Reported as:
Count of participants · Participants
Number of Responders V4
ParticipantsGERDOFF® + OmeprazoleOmeprazole
Yes2320
No816
Statistical analysis
  • GERDOFF® + Omeprazole vs Omeprazole · Chi-squared · p = 0.0496
SecondaryNumber of Responders V6

Responder patients of Group Gerdoff® + omeprazole were randomly assigned to receive a treatment with Gerdoff®-one tablet three times daily- All patients received a packaging of omeprazole, to be taken only if necessary, at constant dose and according to the indications of the Investigator. The scheduled duration of the follow-up period was 12 weeks. A responder was defined as a patient who at the 6th week of treatment showed a reduction of at least 50% vs. the baseline and an absolute value \< 13 on the RSI questionnaire.

Time frame:
In the Visit 6 at the end of follow-up
Reported as:
Count of participants · Participants
Number of Responders V6
ParticipantsGERDOFF® + OmeprazoleNo Treated
yes97
No01
SecondaryScore of Upper Symptoms Using the Likert Scale at Baseline and in the Visit V4

The Likert scale examines 9 symptoms, to be scored from 0 to 4, with a higher score indication a higher frequency of the symptom (i.e. 0=never, 1=occasionally, 2=sometimes, 3= often, 4=Always); The Likert scale scores of single items are as following: 1. Hoarseness or vocal problem 0 1 2 3 4 2. Throat clearance 0 1 2 3 4 3. Excess of mucus in the throat or retrosternal fall of secretions 0 1 2 3 4 4. Difficulty in swallowing food, fluids or pills 0 1 2 3 4 5. Cough after the meal or after lying 0 1 2 3 4 6. Difficulty in breathing or episodes of choking 0 1 2 3 4 7. Problematic or troublesome cough 0 1 2 3 4 8. Sensation of something blocked or mass in the throat 0 1 2 3 4 9. Stomach burning, thoracic pain, poor digestion of gastric acid that moves upright 0 1 2 3 4. Subscales are summarized to compute a total score (total score ranges from 0-36). The mean values of Likert scale total score are reported.

Time frame:
At baseline and in the visit 4
Reported as:
Mean · Score on a scale
Score of Upper Symptoms Using the Likert Scale at Baseline and in the Visit V4
Score on a scaleGERDOFF® + OmeprazoleOmeprazole
Baseline19.0 ± 4.30121 ± 4.557
Visit 47.4 ± 5.66711.6 ± 8.083
Statistical analysis
  • GERDOFF® + Omeprazole vs Omeprazole · ANOVA · p = 0.0065
SecondaryPresence of Upper Symptoms at Visit 4, Using the RSI Questionnaire

The Reflux Symptom Index questionnaire examines 9 items, to be scored from 0 to 5, with a higher score indication a higher severity of the symptom (range of total score: 0-45).

Time frame:
At visit 4 after weeks of treatment
Reported as:
Count of participants · Participants
Presence of Upper Symptoms at Visit 4, Using the RSI Questionnaire
ParticipantsGERDOFF® + OmeprazoleOmeprazole
Missing14
1 symptom72
2 symptoms69
3 symptoms1311
4 symptoms47
5 symptoms02
6 symptoms01
SecondaryUse of Rescue Medication (Omeprazole) During the Treatment

In the first 6 weeks of treatment, the intake in each treatment group of the rescue medication, allowed or not allowed, was calculated as the frequency of intake of the specific drug and the comparison between groups was performed using the Fisher's exact test.

Time frame:
From baseline to visit 4
Reported as:
Count of participants · Participants
Use of Rescue Medication (Omeprazole) During the Treatment
ParticipantsGERDOFF® + OmeprazoleOmeprazole
Yes2428
No118
SecondaryUse of Rescue Medication (Omeprazole) During the Follow-up

During the follow-up, the intake in each treatment group of the rescue medication, allowed or not allowed, was calculated as the frequency of intake of the specific drug.

Time frame:
In the Visit 6 after 12 weeks from baseline
Reported as:
Count of participants · Participants
Use of Rescue Medication (Omeprazole) During the Follow-up
ParticipantsGERDOFF® + OmeprazoleNo Treated
Yes75
No23
SecondaryUse of Rescue Medication (Other Than Omeprazole) During Treatment

During treatment, the intake in each treatment group of the rescue medication, allowed or not allowed, was calculated as the frequency of intake of the specific drug.

Time frame:
From baseline to visit 4
Reported as:
Count of participants · Participants
Use of Rescue Medication (Other Than Omeprazole) During Treatment
ParticipantsGERDOFF® + OmeprazoleOmeprazole
Yes04
No3132
SecondaryPatients'Satisfaction

This evaluation was expressed with a semi-quantitative ordinal scale: 0 = low, 1 = discrete, 2 = good, 3 = excellent).

Time frame:
At visit 4 after weeks of treatment
Reported as:
Count of participants · Participants
Patients'Satisfaction
ParticipantsGERDOFF® + OmeprazoleOmeprazole
Missing10
Low31
Discrete17
Good1111
Excellent1517

Adverse events

Collected over During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
GERDOFF® + Omeprazole0/35 (0%)0/35 (0%)14/35 (40%)
Omeprazole0/36 (0%)1/36 (2.8%)12/36 (33.3%)
Most frequent serious events
Most frequent serious events
EventGERDOFF® + OmeprazoleOmeprazole
Atrial fibrillationCardiac disorders0/351/36
Most frequent other events
Showing 10 of 26
Most frequent other events
EventGERDOFF® + OmeprazoleOmeprazole
NauseaGastrointestinal disorders4/353/36
Flu-like symptomsGeneral disorders3/352/36
MigraineNervous system disorders2/350/36
PyrexiaGeneral disorders0/352/36
DiarrheaGastrointestinal disorders0/352/36
NasopharyngitisInfections and infestations1/352/36
Red blood cell sedimentation rate increasedInvestigations1/350/36
C-reactive protein increased subjects affected / exposedInvestigations1/350/36
HypersensitivityImmune system disorders1/350/36
BronchospasmRespiratory, thoracic and mediastinal disorders1/350/36

Baseline characteristics

Age, Continuous
Age, Continuous(years)GERDOFF® + OmeprazoleOmeprazoleTotal
Median46.0 (20 to 86)45.0 (20 to 76)46.0 (20 to 86)
Sex: Female, Male
Sex: Female, Male(Participants)GERDOFF® + OmeprazoleOmeprazoleTotal
Female223254
Male13417
Race (NIH/OMB)
Race (NIH/OMB)(Participants)GERDOFF® + OmeprazoleOmeprazoleTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White353671
More than one race000
Unknown or Not Reported000
Patients with simultaneous symptoms
Patients with simultaneous symptoms(participants)GERDOFF® + OmeprazoleOmeprazoleTotal
1 symptom235
2 symptoms516
3 symptoms9615
4 symptoms111728
5 symptoms5510
6 symptoms235
7 symptoms112
Hoarseness or vocal problem
Hoarseness or vocal problem(participants)GERDOFF® + OmeprazoleOmeprazoleTotal
yes211839
no141832
Throat clearance
Throat clearance(participants)GERDOFF® + OmeprazoleOmeprazoleTotal
yes182341
no171330
Excess of mucus in the throat or retrosternal fall of secretions
Excess of mucus in the throat or retrosternal fall of secretions(participants)GERDOFF® + OmeprazoleOmeprazoleTotal
yes141529
no212142
Difficulty in swallowing food, fluids or pills
Difficulty in swallowing food, fluids or pills(participants)GERDOFF® + OmeprazoleOmeprazoleTotal
yes7714
no282957

8 further baseline measures are reported on the registry.

08

Study locations

1 site
  • dr Alessandro Repici
    Rozzano, MI 20089, Italy
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2017 to primary completion in Sep 2018, 16 months.

Results were first posted in Mar 2020, 1 year 5 months after primary completion.

Of 33 industry-sponsored interventional studies with no phase under Gastroesophageal Reflux, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's 16 months is below that.

Counting every sponsor, half of 225 studies reached it within 32 months; a quarter within 12 and three quarters within 68.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 11, 2018
First posted
Jan 4, 2019
StartActual
May 5, 2017
Primary completionActual
Sep 20, 2018
CompletionActual
Dec 11, 2018
Results first posted
Mar 18, 2020
Last update
Mar 31, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 31, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03793556
Lead sponsor
SOFAR S.p.A.
Responsible party
Sponsor
First posted
Jan 4, 2019
Start date
May 5, 2017
Primary completion
Sep 20, 2018
Completion
Dec 11, 2018
Results posted
Mar 18, 2020
Last update
Mar 31, 2020

Study contacts

Alessandro Repici, MD
principal investigator · Istituto Clinico Humanitas

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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Discussion

Questions 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.

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