Phase 3 Study With Cadazolid in CDAD (AC061A302)
Subjects with CDAD are randomized and then treated with study drug for 10 days. At the end of treatment, cure is assessed; subjects are then followed-up to assess any disease recurrence.
Clostridium Difficile Associated Diarrhea
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||AC-061A302, A Multi-center, Randomized, Double-blind Study to Compare the Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea (CDAD).|
- Clinical Cure at End of Treatment [ Time Frame: End of Treatment(10 days after starting study drug) +2days ] [ Designated as safety issue: No ]Resolution of Diarrhea AND No additional CDAD treatment.
- Sustained Cure [ Time Frame: End of Treatment(10 days after starting study drug) +28-32 days ] [ Designated as safety issue: No ]Clinical Cure AND No Recurrence.
- Time to Resolution of Diarrhea [ Time Frame: Baseline to End of Treatment(10 days after starting study drug) ] [ Designated as safety issue: No ]The time between the first dose of study drug and Resolution of Diarrhea.
- CDAD Symptoms [ Time Frame: Baseline to End of Treamtent(10 days after starting study drug) +2 days ] [ Designated as safety issue: No ]Change from baseline to End of Treatment +2days in CDAD Symptoms as measured by the DaySyms Patient Reported Outcome (PRO).
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Vancomycin
Vancomycin 125 mg qid or matching placebo capsules
Oral vancomycin 125 mg or matching placebo capsules 4 times daily
Other Name: vancomycin
Cadazolid 250 mg bid or matching placebo granules
Cadazolid 250 mg or matching placebo oral suspension twice daily.
Other Name: ACT-179811
An interventional study to investigate the efficacy and safety of cadazolid versus vancomycin in subjects with Clostridium difficile-Associated Diarrhea (CDAD).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01983683
|Contact: Global Medical Informationfirstname.lastname@example.org|
Show 80 Study Locations
|Study Director:||Paul McGovern, MD||Actelion|