Effect of omeprazole on the treatment of gastroesophageal reflux disease
Phase 2
- Conditions
- Gastro-oesophageal reflux disease.Gastro-oesophageal reflux disease with oesophagitis
- Registration Number
- IRCT201112135330N2
- Lead Sponsor
- Tabriz university of medical sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Infants 2-12 months with body weight over 2.5 kg and full term pregnancy, who had GERD.
Exclusion Criteria
Children with previous gastrointestinal surgery, neurologic disease, significant hepatic or renal impairment or a history of significant cardiac or respiratory disease, a history of peptic ulcer disease, proven lactose intolerance, or cow’s milk protein intolerance; All children hadn’t parental reassurance, use antacids, H2-antagonists, and proton pump inhibitors [PPIs] 4 week before study were excluded.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Weekly GERD symptom score (WGSS). Timepoint: during 2 weeks. Method of measurement: sum of the 5 selected individual weekly GERD symptom mean frequencies for vomiting/regurgitation (1a), irritability/fussiness (2b), choking/gagging (3a), arching back (4a), and refusal to feed (higher score of 5a and 5b).
- Secondary Outcome Measures
Name Time Method ack of efficacy per withdrawal criteria, growth parameter. Timepoint: week 4-8. Method of measurement: withdrawal for any reason, time to withdrawal due to lack of efficacy, time to withdrawal for any reason, weekly GERD symptom score (WGSS) ,Physical examinations.