Condition category
Digestive System
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In Western countries, 20% to 40% of adults suffer from episodes of heartburn due to gastroesophageal reflux disease (GERD), where acid leaks out of the stomach and up into the gullet, causing burning chest pain after eating. The aim of this study is to compare the short-term effectiveness and safety of two treatments for moderate GERD in a general practice setting: an alginate (Gaviscon®) and a proton pump inhibitor (omeprazole).

Who can participate?
Men and women aged between 18 and 60 who experience GERD/heartburn 2 to 6 days per week.

What does the study involve?
Participants are randomly allocated to be treated with either Gaviscon® or omeprazole.

What are the possible benefits and risks of participating?
Gaviscon may cause constipation, and omeprazole may cause diarrhea, constipation, stomach ache, nausea/vomiting, vertigo headaches, rash or itching.

Where is the study run from?
The study is a multicentre study carried out in France: 75 general physicians are involved as investigators.

When is the study starting and how long is it expected to run for?
August to December 2010.

Who is funding the study?
Reckitt Benckiser Healthcare France

Who is the main contact?
Dr Denis Pouchain

Trial website

Contact information



Primary contact

Dr Denis Pouchain


Contact details

1 Ter
Rue du Midi

Additional identifiers

EudraCT number

2010-019563-11 number

Protocol/serial number


Study information

Scientific title

Non-inferiority randomised, double-blind study comparing the efficacy of Gaviscon in oral suspension to 20mg omeprazole on pyrosis in patients with gastroesophageal reflux (GER) in which the current episode has not been treated with patient self-reporting questionnaires over a 14-day period.



Study hypothesis

The hypothesis is that the proton pump inhibitor (PPI) chosen within the context of the study will have a period of 2 days and a standard deviation of 1.0 days; the non-inferiority hypothesis will be achieved if Gaviscon does not differ by 0.5 of a day

Ethics approval

Ethics Committee to Protect People, Ile-de-France VIII [Comité de Protection des Personnes d’Île-de-France VIII], 03/05/2010

Study design

Randomised double-blind controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Gastroesophageal reflux disease (GERD) with pyrosis


Comparing Gaviscon oral solution to omeprazole 20 mg with daily measurements by the patient and two visits at Day 7 and Day 14 by the doctor.

Each patient agrees to be monitored by his/her investigator at 3 visits over 14 days: at the inclusion, at an interim visit on Day 7 and then at a final visit on Day 14. No laboratory or diagnostic examination will be requested throughout the duration of the study.

Intervention type



Not Applicable

Drug names

Gaviscon, omeprazole

Primary outcome measure

Time period for obtaining 24 hour consecutive relief as evaluated on Day 7 using the patients' weekly diary - calculated through the daily recording of episodes of pyrosis by the patient in his/her self-questionnaire.

Secondary outcome measures

1. The number of patients without pyrosis pain at day 7
2. The number of patients presenting with greater comfort at day 7 and day 14 (on a 5 point Likert scale)

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Male or female patient
2. Aged 18 to 60 years
3. Patient with between 2 and 6 episodes of GER per week with pyrosis, with or without regurgitation
4. Patient not been treated for at least 2 months with an alginate/antacid combination or a proton pump inhibitor (PPI)
5. Patient with signed informed consent form for participation in the study
6. Patient able to understand and fill out the study self-questionnaires
7. Patient affiliated with a national social security scheme
8. Women using a form of contraception

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Patient with less than 2 episodes or over 6 episodes of GER with pyrosis per week
2. Patient being treated with an alginate/antacid combination and/or a PPI in the two months preceding the inclusion
3. Patient with mainly atypical, gastrointestinal or extra-intestinal symptoms, without symptoms of pyrosis
4. Patient treated with clopidogrel
5. Patient followed for a gastric or duodenal ulcer
6. Patient with surgery of the upper digestive tract
7. Patient with a neoplastic disorder of the upper digestive tract or ear, nose and throat
8. Patient with known hypersensitivity to one of the components of Gaviscon and/or omeprazole
9. Patient treated with atazanavir in combination with rotonavir
10. Patient treated with ketoconazole and/or itraconazole
11. Patient with known hypersensitivity to the benzimidazoles
12. Breastfeeding women or those with known pregnancy
13. Patient that refuses to participate in a clinical trial

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

1 Ter

Sponsor information


Reckitt Benckiser Healthcare (France)

Sponsor details

c/o Gaelle Rocheteau
15 rue Ampère
Massy Cedex

Sponsor type




Funder type


Funder name

Reckitt Benckiser Healthcare (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes