Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(Sponsor request)
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Identifier:
First received: January 20, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted

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).

Condition Intervention Phase
Gastroesophageal Reflux
Drug: Placebo
Drug: Cisapride
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Caregiver's assessment of infant pediatric GORD symptoms [ Time Frame: Up to 8 weeks (56 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number and type of adverse events reported [ Time Frame: From time of first dose to the last dose (up to 8 weeks) ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: September 2003
Study Completion Date: October 2003
Arms Assigned Interventions
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.

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.


Ages Eligible for Study:   1 Month to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01281553

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Portfolio/CDT Leader, Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Identifier: NCT01281553     History of Changes
Other Study ID Numbers: CR003952, CIS-INT-27
Study First Received: January 20, 2011
Last Updated: January 20, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Cisapride (PREPULSID)
Gastroesophageal Reflux Disease (GERD)
Gastro-oesophageal Reflux Disease (GORD)

Additional relevant MeSH terms:
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Serotonin Agents
Serotonin Receptor Agonists
Therapeutic Uses processed this record on February 27, 2015