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 |
| Protocol serial number | N0264130004 |
| Sponsor | Department of Health |
| Funder | United Bristol Healthcare NHS Trust |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Domperidone and omeprazole |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 16 Years |
| Sex | Not Specified |
| 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
- United Kingdom
- England
Study participating centre
C/O Research & Effectiveness Department
Bristol
BS2 8HW
United Kingdom
BS2 8HW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
