Effect of domperidone and omeprazole in gastro-oesophageal reflux disease in infants between 0 and 2 years. - Treatment with domperidone and omeprazole in GERD

Active, not recruiting

• Conditions: Gastro-oesophageal reflux disease; MedDRA 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

Study Timeline

• Study Start: 2009-06-11
• Last Update Posted: 2012-03-19

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