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

January 20, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Study Completion (Actual)

October 1, 2003

Study Registration Dates

First Submitted

January 20, 2011

First Submitted That Met QC Criteria

January 20, 2011

First Posted (Estimate)

January 24, 2011

Study Record Updates

Last Update Posted (Estimate)

January 24, 2011

Last Update Submitted That Met QC Criteria

January 20, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR003952
  • CIS-INT-27

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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