A Study of Cisapride in Patients With Symptomatic Gastro-Oesophageal Reflux Disease
|ClinicalTrials.gov Identifier: NCT01281553|
Recruitment Status : Terminated (Sponsor request)
First Posted : January 24, 2011
Last Update Posted : January 24, 2011
|Condition or disease||Intervention/treatment||Phase|
|Gastroesophageal Reflux||Drug: Placebo Drug: Cisapride||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Start Date :||September 2003|
|Actual 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.
- Caregiver's assessment of infant pediatric GORD symptoms [ Time Frame: Up to 8 weeks (56 days) ]
- The number and type of adverse events reported [ Time Frame: From time of first dose to the last dose (up to 8 weeks) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01281553
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|