A Study of Cisapride in Patients With Symptomatic Gastro-Oesophageal Reflux Disease

• Status: Terminated
• Trial end date: 2003-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the efficacy and tolerability of cisapride with placebo in infants and children with gastro-oesophageal reflux disease (GORD).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Cisapride

Criteria

Inclusion Criteria:

• Diagnosis of GORD based on protocol-specified characteristics

• Failed the 1st of 5 stepwise treatments for GORD recommended by the European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN)

• Caregiver able to complete the I-GERQ-R questionnaire

Exclusion Criteria:

• Protocol-specified respiratory conditions requiring previous or current treatment with oral or intravenous corticosteroids (prior and concurrent use of inhaled corticosteroids is acceptable)

• Cause of vomiting/regurgitation other than GORD

• Prior history of cisapride intake