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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2003-10-31

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).

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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.

Conditions

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Gastroesophageal Reflux

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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001

Cisapride 0.2 mg/kg suspension q.i.d.for 8 weeks.

Group Type EXPERIMENTAL

Cisapride

Intervention Type DRUG

0.2 mg/kg suspension q.i.d.for 8 weeks.

002

Placebo Suspension identical in appearance to cisapride q.i.d. for 8 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Suspension identical in appearance to cisapride q.i.d. for 8 weeks.

Interventions

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Placebo

Suspension identical in appearance to cisapride q.i.d. for 8 weeks.

Intervention Type DRUG

Cisapride

0.2 mg/kg suspension q.i.d.for 8 weeks.

Intervention Type DRUG

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

Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No