Efficacy of domperidone and/or omeprazole in the treatment of gastroesophageal reflux (GOR) in children - a comparative study
| ISRCTN | ISRCTN40276556 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40276556 |
| Secondary identifying numbers | N0264130004 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 19/10/2016
- 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
Prof B K Sandhu
Scientific
Scientific
C/O Research & Effectiveness Department
Level 1, The Old Building
Bristol Royal Infirmary
Malborough Street
Bristol
BS2 8HW
United Kingdom
| Phone | +44 (0)117 928 3473 |
|---|---|
| r&eoffice@ubht.swest.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | Efficacy of domperidone and/or omeprazole in the treatment of gastroesophageal reflux (GOR) in children - a comparative study |
| Study objectives | The aim of this study is to document the efficacy of domperidone and/or omeprazole in neurologically normal and abnormal children found to have significant GOR on oesophageal pH monitoring. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Gastro-oesophageal reflux disease (GORD) |
| Intervention | Double blind placebo controlled prospective randomised controlled trial. Randomised to: A. Domperidone B. Omeprazole C. Combination of both |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Domperidone and omeprazole |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/03/2004 |
| Completion date | 01/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 16 Years |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | 1. Children under 16 2. Reflux index >1 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/03/2004 |
| Date of final enrolment | 01/05/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
C/O Research & Effectiveness Department
Bristol
BS2 8HW
United Kingdom
BS2 8HW
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
United Bristol Healthcare NHS Trust
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
19/10/2016: No publications found in PubMed, verifying study status with principal investigator.
