Effect of domperidone and omeprazole in gastro-oesophageal reflux disease in infants between 0 and 2 years. - Treatment with domperidone and omeprazole in GERD
- Conditions
- Gastro-oesophageal reflux diseaseMedDRA version: 9.1Level: LLTClassification code 10017924Term: Gastroesophageal reflux
- Registration Number
- EUCTR2007-003067-46-NL
- Lead Sponsor
- Flevoziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Gastro-oesophageal reflux disease diagnosed by 24-h oesophageal pH monitoring in infants aged 0-2 years
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1. Gastro-oesophageal reflux disease for which treatment has started. 2. Infants with gastro-oesophageal reflux disease presenting with an apparant life threatening event (ALTE)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To measure the effect of domperidone and omeprazole on reflux-time, duration, and symptoms of GERD <br>;Secondary Objective: Growth, relieve of complaints;Primary end point(s): Change in reflux time, reflux duration and symptoms before and after treatment as measured by 24-h oesophageal pH monitoring, questionnairies, patient controle. <br>
- Secondary Outcome Measures
Name Time Method