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

Gastroesophageal Reflux Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01281553
• Other study ID #: CR003952
• Secondary ID: CIS-INT-27
• Status: Terminated
• Phase: Phase 4
• First received: January 20, 2011
• Last updated: January 20, 2011
• Start date: September 2003
• Est. completion date: October 2003

Study information

• Verified date: January 2011
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 18 Months

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Drug:
• Placebo
Suspension identical in appearance to cisapride q.i.d. for 8 weeks.
• Cisapride
0.2 mg/kg suspension q.i.d.for 8 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caregiver's assessment of infant pediatric GORD symptoms		Up to 8 weeks (56 days)	No
Secondary	The number and type of adverse events reported		From time of first dose to the last dose (up to 8 weeks)	No