Efficiency of Proton pump Inhibitors in Patients with gastro-oesophageal reflux symptoms
| ISRCTN | ISRCTN68985072 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68985072 |
| Secondary identifying numbers | N/A |
- Submission date
- 24/10/2006
- Registration date
- 24/04/2007
- Last edited
- 22/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr P J F de Jonge
Scientific
Scientific
's-Gravendijkwal 230
Rotterdam
3015 CE
Netherlands
| Phone | +31 (0)10 463 5528 |
|---|---|
| p.dejonge@erasmusmc.nl |
Study information
| Study design | Randomised multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Multi-centre |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Efficiency of Proton pump Inhibitors in Patients with gastro-oesophageal reflux symptoms |
| Study acronym | PIP study |
| Study objectives | 1. To determine subgroups of patients with gastro-oesophageal reflux symptoms according to endoscopy and pH monitoring 2. To evaluate the differences in the subgroups of patients with Gastro-oEsophageal Reflux Disease (GERD) symptoms in: a. duration of Proton Pump Inhibitor (PPI) treatment (four versus eight weeks) b. inflammatory reaction c. prevalence of Helicobacter pylori d. occurrence of symptoms 3. To evaluate treatment of GERD patients with PPIs for four or eight weeks in order to determine the effectiveness of the PPI treatment 4. To evaluate the effect of PPI treatment on: a. symptom relief b. inflammatory reaction in the oesophagus |
| Ethics approval(s) | Approval received from the Medical Ethics Committee (Medisch Ethische Toetsings Commissie Erasmus MC) (ref: MEC-2005-141). |
| Health condition(s) or problem(s) studied | Gastro-oesophageal reflux disease |
| Intervention | All patients will undergo a baseline endoscopy and follow up endoscopy with biopsies, then they all will undergo a wireless oesophageal 48 hour pH monitoring study, and finally these patients will be randomised to either four weeks or eight weeks of 20 mg once daily rabeprazole treatment. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Rabeprazole |
| Primary outcome measure | Differences in the subgroups of patients with GERD symptoms in: 1. Duration of PPI treatment (four versus eight weeks) 2. Inflammatory reaction 3. Prevalence of H. pylori 4. Occurrence of symptoms |
| Secondary outcome measures | Effect of PPI treatment on: 1. Symptom relief 2. Inflammatory reaction in the oesophagus |
| Overall study start date | 01/10/2005 |
| Completion date | 01/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 415 |
| Key inclusion criteria | 1. Aged 18 years or older 2. Symptoms of GERD as determined by the GERD-Health Related Quality of Life (HRQL) questionnaire (score more than or equal to 12) 3. Informed consent |
| Key exclusion criteria | 1. Aged under 18 years 2. Unable to fill out questionnaire 3. Previous history of upper Gastro-Intestinal (GI) tract cancer 4. Previous history of achalasia 5. Previous surgery to the oesophagus or stomach 6. Endoscopically demonstrated and histologically proven complicated reflux disease (ulcer, stricture, Barretts esophagus) 7. Coagulation disorder if uncorrected at the time of endoscopy 8. Use of warfarin or other anti-coagulant medication if uncorrected at the time of endoscopy 9. Liver cirrhosis 10. Pregnancy and lactation 11. Contraindications to the study medication |
| Date of first enrolment | 01/10/2005 |
| Date of final enrolment | 01/10/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
's-Gravendijkwal 230
Rotterdam
3015 CE
Netherlands
3015 CE
Netherlands
Sponsor information
Erasmus Medical Center (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
University Medical Center Rotterdam
s-Gravendijkwal 230
Rotterdam
3015 CE
Netherlands
| Phone | +31 (0)10 463 55 28 |
|---|---|
| p.dejonge@erasmusmc.nl | |
| Website | http://www.erasmusmc.nl/content/englishindex.htm |
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Industry
Janssen & Cilag B.V. (The Netherlands)
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 |
Editorial Notes
22/09/2021: Proactive update review. No publications found. Search options exhausted.
