Efficacy Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D) (ARDIS-1)
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|ClinicalTrials.gov Identifier: NCT00552565|
Recruitment Status : Completed
First Posted : November 2, 2007
Last Update Posted : June 11, 2009
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome With Diarrhea||Drug: Rezular 15mg Drug: Placebo Drug: Rezular||Phase 3|
We have fulfilled our enrollment requirements for this study.
This study has been designed as a multicenter, randomized, double-blind, placebo controlled parallel dose group trial. The study will be open to both women and men. At screening the patient will be assessed to see if they meet the Rome III criteria for IBS-D. After screening, patients will undergo a 14-day run-in period evaluation, during which eligibility to be randomized to drug or placebo will be determined. Patients will complete daily telephone diaries during the run-in and double-blind phases of the study. Patients will be evaluated at regularly scheduled clinic visits during double-blind phase of the study.
Patients who complete the study may have the opportunity to rollover to the open-label one-year safety study (ARDIS-3).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||711 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
|Placebo Comparator: 1||
Drug: Rezular 15mg
|Experimental: Rezular 37.5mg||
Rezular 37.5mg 3xday up to 12 weeks
|Experimental: Rezular - 75mg||
Rezular 75mg 3xday up to 12 weeks
- Adequate Relief [ Time Frame: 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): NCT00552565
|United States, North Carolina|
|Wilmington, North Carolina, United States, 28401|