9 completed. 3 Phase 3, 3 Phase 4, 2 Phase 2, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 3 | Completed 3 |
| Phase 4 | 3 | Completed 3 |
| Phase 2 | 2 | Completed 2 |
| Phase 1 | 1 | Completed 1 |
Follow this drug Literature Review of OPT 80 trials Research Report on OPT 80
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Comparison of Fidaxomicin and Vancomycin in Patients With CDI Receiving Antibiotics for Concurrent Infections Fidaxomicin, Vancomycin - Clostridium Difficile Infection (CDI) | Phase 4 | Completed | University of Michigan | 144 | 2017-05-01 | 2022-03-25 |
| Study to Evaluate the Pharmacokinetics of Fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects With Clostridium Difficile Infection (CDI) fidaxomicin - Inflammatory Bowel Disease (IBD), Clostridium Difficile Infection (CDI) | Phase 4 | Completed | Astellas Pharma Europe Ltd. | 25 | 2015-08-13 | 2024-10-31 |
| A Phase IIIB/IV Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration of Fidaxomicin Therapy in the Clinical Cure of Clostridium Difficile Infection (CDI) in an Older Population Fidaxomicin, Vancomycin - Clostridium Difficile | Phase 4 | Completed | Astellas Pharma Europe Ltd. | 364 | 2014-11-06 | 2024-10-31 |
| A Study to Compare Safety and Efficacy of OPT-80(Fidaxomicin) With Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea (CDAD) OPT-80, vancomycin - Clostridium Difficile | Phase 3 | Completed | Astellas Pharma Inc | 210 | 2014-06-23 | 2024-10-31 |
| A Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Fidaxomicin in Healthy Male Japanese and Caucasian Subjects Fidaxomicin, Placebo - Pharmacokinetics of Fidaxomicin, Healthy Subjects | Phase 1 | Completed | Astellas Pharma Global Development, Inc. | 36 | 2013-02-01 | 2014-05-21 |
| Safety and Efficacy of Fidaxomicin Versus Placebo for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation (MK-5119-001) fidaxomicin, Placebo - Clostridium Difficile-Associated Diarrhea (CDAD) | Phase 3 | Completed | Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | 611 | 2012-10-10 | 2018-09-18 |
| Safety, Tolerability, and Pharmacokinetics of Fidaxomicin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD) fidaxomicin - Clostridium Difficile-associated Diarrhea | Phase 2 | Completed | Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | 38 | 2012-06-15 | 2018-09-18 |
| Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (MK-5119-018) Fidaxomicin, Vancomycin, Matching Placebo to Fidaxomicin - Clostridium Infections, Diarrhea | Phase 3 | Completed | Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | 629 | 2006-05-02 | 2017-04-21 |
| OPT-80 in Clostridium Difficile-Associated Diarrhea (CDAD) OPT-80 - Diarrhea | Phase 2 | Completed | Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | 2004-11-01 | 2017-03-27 |
Clostridium Infections (3) · Diarrhea (3) · Infections (1) · Inflammatory Bowel Diseases (1)
Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) (4) · Astellas Pharma Europe Ltd. (2) · Astellas Pharma Global Development, Inc. (1) · Astellas Pharma Inc (1) · University of Michigan (1)
United States (3) · Austria (2) · France (2) · Greece (2) · Italy (2) · Poland (2) · Russia (2) · United Kingdom (2) · Belgium (1) · Croatia (1) · Czechia (1) · Denmark (1) · Finland (1) · Germany (1) · Hungary (1)
PMID 18955525, PMID 21288078, PMID 22752857, PMID 22752860, PMID 22752862, PMID 22752865, PMID 23715579, PMID 24599770, PMID 28575523, PMID 29273269, PMID 29893798, PMID 29934056, PMID 30260412, PMID 30911926, PMID 36906440, PMID 37797310
2014 (1)