An Efficacy and Safety Study of Cisapride for Improving Symptoms Associated With Gastroparesis in Patients With Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT01286090|
Recruitment Status : Terminated (Sponsor request)
First Posted : January 31, 2011
Last Update Posted : January 31, 2011
|Condition or disease||Intervention/treatment||Phase|
|Gastroparesis Diabetes Mellitus||Drug: Cisapride Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Double-Blind, Randomized, Placebo-Controlled Trial to Assess Efficacy and Safety of R051619 (Cisapride 10 mg Q.I.D.) Versus Placebo for the Improvement of Symptoms Associated With Exacerbations of Gastroparesis, After Failure of Other Treatments, in Patients With Diabetes Mellitus|
|Study Start Date :||July 2003|
|Study Completion Date :||October 2003|
Cisapride One 10-mg tablet taken orally 4 times a day for up to 8 weeks.
One 10-mg tablet taken orally 4 times a day for up to 8 weeks.
Placebo One tablet taken orally 4 times a day for up to 8 weeks.
One tablet taken orally 4 times a day for up to 8 weeks.
- The change from baseline in Gastroparesis Cardinal Symptoms Index (GCSI) score [ Time Frame: At baseline (Visit 2) and weekly during the treatment phase of the trial for up to 8 weeks ]
- The number of adverse events reported [ Time Frame: For the duration of the study (up to 8 weeks) ]
- The type of adverse events reported [ Time Frame: For the duration of the study (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): NCT01286090
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|