Contact information
Type
Scientific
Primary contact
Prof B K Sandhu
ORCID ID
Contact details
C/O Research & Effectiveness Department
Level 1
The Old Building
Bristol Royal Infirmary
Malborough Street
Bristol
BS2 8HW
United Kingdom
+44 (0)117 928 3473
r&eoffice@ubht.swest.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0264130004
Study information
Scientific title
Efficacy of domperidone and/or omeprazole in the treatment of gastroesophageal reflux (GOR) in children - a comparative study
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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 names
Domperidone and omeprazole
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/03/2004
Overall trial end date
01/05/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Children under 16
2. Reflux index >1
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/03/2004
Recruitment end date
01/05/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
C/O Research & Effectiveness Department
Bristol
BS2 8HW
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
United Bristol Healthcare NHS Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary