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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Gastroesophageal Reflux

Intervention / Treatment
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* Drug: Placebo
* Drug: Cisapride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 001<br>Cisapride 0.2 mg/kg suspension q.i.d.for 8 weeks. | Drug: Cisapride<br>* 0.2 mg/kg suspension q.i.d.for 8 weeks.<br>|
| Placebo Comparator: 002<br>Placebo Suspension identical in appearance to cisapride q.i.d. for 8 weeks. | Drug: Placebo<br>* Suspension identical in appearance to cisapride q.i.d. for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiver's assessment of infant pediatric GORD symptoms |  | Up to 8 weeks (56 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number and type of adverse events reported |  | From time of first dose to the last dose (up to 8 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cisapride (PREPULSID), Placebo, Gastroesophageal Reflux Disease (GERD), Gastro-oesophageal Reflux Disease (GORD)