effect of omeprazole and es-omeprazole in reflux disease

Phase 3

• Conditions: GERD.; Gastro-esophageal reflux disease without esophagitis; K21.9

• Registration Number: IRCT20191027045256N1
• Lead Sponsor: Kashan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 March 2020

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Infants 1 to 11 months of age with clinical diagnosis of reflux based on symptoms or endoscopic evidence

Exclusion Criteria

Using a PPI in the last 7 days
Treatment for reflux symptoms, including histamine 2 receptor antagonists, procinetics, and bismuth-containing antacids within 24 hours before intervention
Patients with active gastrointestinal bleeding, apnea, allergic gastroenteritis, eosinophilic gastroenteritis, bleeding disorders, pyloric stenosis, active seizure disorder, acute pancreatitis or meningitis

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect of Omeprazole and S-Omeprazole in Children. Timepoint: Symptoms evaluated included vomiting, contractility, irritability, hyper-esophageal and respiratory disorders (eg cough, wheezing / steroids) and nutritional problems (eg, dizziness / choking). 1 hour will be defined. Vomiting / regurgitation volume will be classified as small (5-15 ml), medium (15-30 ml), large (more than 30 ml) at any time of 4 weeks. Method of measurement: Recovery involves reducing the severity of symptoms to more than half of the initial symptom score (before the intervention).