A Study of Cisapride in Patients With Symptomatic Gastro-Oesophageal Reflux Disease
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 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|
- Caregiver's assessment of infant pediatric GORD symptoms [ Time Frame: Up to 8 weeks (56 days) ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||September 2003|
|Study Completion Date:||October 2003|
Cisapride 0.2 mg/kg suspension q.i.d.for 8 weeks.
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.
Suspension identical in appearance to cisapride q.i.d. for 8 weeks.
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 Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|