Efficacy of domperidone and/or omeprazole in the treatment of gastroesophageal reflux in children - a comparative study.
| DEC-NET Serial number GB279 | |
| Published online | 07/07/2004 14.46.00 |
| Last updated | 02/08/2005 14.06.13 |
| Other protocol ID number | N0264130004 |
| This trial has been approved by an ethics committee | |
| Current trial status | Open (actively recruiting new participants) |
| Major Disease (ICD9 class) | ESOPHAGEAL REFLUX |
| Experimental drug | |
| DOMPERIDONE | |
| Omeprazole | |
| Gender | Both |
| Age (range) | <16 years |
Eligibility criteria | |
| Inclusion criteria | |
| Children under 16 with a reflux index >1 | |
| Exclusion criteria | |
| Informed consent not given | |
Trial design/methodology | |
| Phase | 3 |
| Kind of study | Efficacy |
| Design | Controlled Randomised Blinded Double blind |
| Purpose of study | |
| To document the efficacy of domperidone and/or omeprazole in neurologically normal and abnormal children found to have significant GOR on oesophageal pH monitoring | |
| Summary of study design, objectives, and ongoing research findings | |
| Double blind placebo controlled prospective randomised controlled trial. Randomised to A]domperidone B]omeprazole C]combination of both. The aim of the 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 | |
| Principal investigator | |
| Name | Professor B K Sandhu |
| Institution | Bristol Royal Infirmary |
| Postal address | C/O Research & Effectiveness Department, Level 1, The Old Building, Bristol Royal Infirmary, Malborough Street, BRISTOL, BS2 8HW |
| City | BRISTOL |
| Country | UNITED KINGDOM |
| Phone | 0117 928 3473 |
| Fax | 0117 928 3524 |
| r&eoffice@ubht.swest.nhs.uk | |
| Sponsor name |
| United Bristol Healthcare NHS Trust (Academic Institution) |
| ISRCTN | EudraCT |
