NCT01281553

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

Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of R051619 (Cisapride Oral Suspension 0.2 mg/kg q.i.d.) for the Treatment of Symptomatic Gastro-Oesophageal Reflux Disease (GORD) in Infants and Children

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: All
• Age: 1 Month – 18 Months
• Healthy volunteers: Not accepted

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).

Detailed description

This is a double-blind (neither patient nor study staff will know the identity of the assigned treatment) study evaluate the effectiveness and safety of cisapride in patients with gastro-oesophageal reflux disease (GORD) (also referred to as gastroesophageal reflux disease \[GERD\[) compared to a placebo (a identical in appearance to cisapride but does not contain active drug). Patients will receive placebo or cisapride suspension at 0.2 mg/kg (volumn determined by patient weight) four times per day (q.i.d.) (15 minutes before feeding 3 times a day and at bedtime) orally (by mouth) for 8 weeks.

Conditions

• Gastroesophageal Reflux

Interventions

Type	Name	Description
DRUG	Placebo	Suspension identical in appearance to cisapride q.i.d. for 8 weeks.
DRUG	Cisapride	0.2 mg/kg suspension q.i.d.for 8 weeks.

Timeline

• Start date: 2003-09-01
• Completion: 2003-10-01
• First posted: 2011-01-24
• Last updated: 2011-01-24