Condition category
Digestive System
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
19/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes

19/10/2016: No publications found in PubMed, verifying study status with principal investigator.