A Study of Cisapride in Patients With Symptomatic Gastro-Oesophageal Reflux Disease
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|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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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.|