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

Phase 4

Terminated

• Conditions: Gastroesophageal Reflux
• Interventions: Drug: Placebo; Drug: Cisapride

• Registration Number: NCT01281553
• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief 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.

Study Timeline

• Study Start: 2003-09
• Study Completion: 2003-10
• Status Verified: 2011-01
• Study First Submitted: 2011-01-20
• Study First Submitted QC: 2011-01-20
• Last Update Submitted: 2011-01-20
• Study First Posted: 2011-01-24
• Last Update Posted: 2011-01-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
002	Placebo	Placebo Suspension identical in appearance to cisapride q.i.d. for 8 weeks.
001	Cisapride	Cisapride 0.2 mg/kg suspension q.i.d.for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Caregiver's assessment of infant pediatric GORD symptoms	Up to 8 weeks (56 days)

Secondary Outcome Measures

Name	Time	Method
The number and type of adverse events reported	From time of first dose to the last dose (up to 8 weeks)