Back to resultsA Study of Cisapride in Patients With Symptomatic Gastro-Oesophageal Reflux Disease
Primary Purpose
Gastroesophageal Reflux
Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Placebo
Cisapride
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux focused on measuring Cisapride (PREPULSID), Placebo, Gastroesophageal Reflux Disease (GERD), Gastro-oesophageal Reflux Disease (GORD)
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
001
002
Arm Description
Cisapride 0.2 mg/kg suspension q.i.d.for 8 weeks.
Placebo Suspension identical in appearance to cisapride q.i.d. for 8 weeks.
Outcomes
Primary Outcome Measures
Caregiver's assessment of infant pediatric GORD symptoms
Secondary Outcome Measures
The number and type of adverse events reported
Full Information
NCT ID
NCT01281553
First Posted
January 20, 2011
Last Updated
January 20, 2011
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1. Study Identification
Unique Protocol Identification Number
NCT01281553
Brief Title
A Study of Cisapride in Patients With Symptomatic Gastro-Oesophageal Reflux Disease
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Terminated
Why Stopped
Sponsor request
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux
Keywords
Cisapride (PREPULSID), Placebo, Gastroesophageal Reflux Disease (GERD), Gastro-oesophageal Reflux Disease (GORD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
001
Arm Type
Experimental
Arm Description
Cisapride 0.2 mg/kg suspension q.i.d.for 8 weeks.
Arm Title
002
Arm Type
Placebo Comparator
Arm Description
Placebo Suspension identical in appearance to cisapride q.i.d. for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Suspension identical in appearance to cisapride q.i.d. for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Cisapride
Intervention Description
0.2 mg/kg suspension q.i.d.for 8 weeks.
Primary Outcome Measure Information:
Title
Caregiver's assessment of infant pediatric GORD symptoms
Time Frame
Up to 8 weeks (56 days)
Secondary Outcome Measure Information:
Title
The number and type of adverse events reported
Time Frame
From time of first dose to the last dose (up to 8 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study of Cisapride in Patients With Symptomatic Gastro-Oesophageal Reflux Disease
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