Study of Gaviscon versus Omeprazole on pyrosis in patients with mODerate gastroesophageal reflux disease in which the current episode has not been treated (GOOD)
| ISRCTN | ISRCTN62203233 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62203233 |
| EudraCT/CTIS number | 2010-019563-11 |
| Secondary identifying numbers | RB10001 |
- Submission date
- 28/10/2011
- Registration date
- 09/11/2011
- Last edited
- 17/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
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
Contact information
Scientific
1 Ter
Rue du Midi
Vincennes
94300
France
Study information
| Study design | Randomised double-blind controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 acronym | GOOD |
| 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(s) | Ethics Committee to Protect People, Ile-de-France VIII [Comité de Protection des Personnes dÎle-de-France VIII], 03/05/2010 |
| Condition | Gastroesophageal reflux disease (GERD) with pyrosis |
| Intervention | 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 | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 27/08/2010 |
| Overall study end date | 13/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 240 |
| Total final enrolment | 278 |
| 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 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 | 27/08/2010 |
| Recruitment end date | 13/12/2010 |
Locations
Countries of recruitment
- France
Study participating centre
94300
France
Sponsor information
Industry
c/o Gaelle Rocheteau
15 rue Ampère
Massy Cedex
91748
France
| Website | http://www.rb.com/fr |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 23/02/2012 | 17/12/2020 | Yes | No |
Editorial Notes
17/12/2020: Publication reference and total final enrolment added.
