Clinical trial
Fidaxomicin Versus Vancomycin for the Treatment of Clostridium…
NCT00314951 · Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), Industry · Completed
Key facts
| NCT number | NCT00314951 |
|---|---|
| Title | Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (MK-5119-018) |
| Official title | A Multi-National, Multi-Center, Double-Blind, Randomized, Parallel Group Study to Compare the Safety and Efficacy of 200 mg PAR-101 Taken q12h With 125 mg Vancomycin Taken q6h for Ten Days in Subjects With Clostridium Difficile-Associated Diarrhea |
| Lead sponsor | Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Clostridium Infections, Diarrhea |
| Intervention type | Drug |
| Interventions | Fidaxomicin, Vancomycin, Matching Placebo to Fidaxomicin |
| Enrollment | 629 |
| Start date | May 2, 2006 |
| Primary completion | Jul 23, 2008 |
| Completion | Aug 21, 2008 |
| First posted | Apr 17, 2006 |
| Last update posted | Apr 21, 2017 |
At a glance
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: