A Study to Compare Safety and Efficacy of OPT-80(Fidaxomicin) With Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
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ClinicalTrials.gov Identifier: NCT02179658 |
Recruitment Status
:
Completed
First Posted
: July 2, 2014
Last Update Posted
: September 29, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Clostridium Difficile | Drug: OPT-80 Drug: vancomycin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 210 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | OPT-80 Phase III Study -A Multi-center, Double Blinded, Randomized, Parallel Group Study To Compare The Safety, Pharmacokinetics And Efficacy of OPT-80 With Vancomycin In Subjects With Clostridium Difficile-Associated Diarrhea (CDAD) |
Study Start Date : | May 2014 |
Actual Primary Completion Date : | September 2016 |
Actual Study Completion Date : | September 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: OPT-80 group
Oral
|
Drug: OPT-80
oral
Other Name: fidaxomicin
|
Active Comparator: Vancomycin group
Oral
|
Drug: vancomycin
oral
|
- Global cure rate [ Time Frame: Up to 38 days ]Global cure rate is the rate of the subjects satisfying both of the following: being cured at the completion of study drug administration; without recurrence during the follow-up period
- Cure rate [ Time Frame: Day 10 -11 of the study period ]
- Recurrence rate of CDAD [ Time Frame: during the 4-week follow-up period, up to Day 38 ]
- Time to resolution of diarrhea [ Time Frame: up to 38 days ]
- Microbiological efficacy [ Time Frame: Up to 38 days ]
- Plasma concentration of OPT-80(fidaxomicin) [ Time Frame: Before administration, Day 1 and Day 10-11 ]
- Plasma concentration of OP-1118 [ Time Frame: Before administration, Day 1 and Day 10-11 ]
- Fecal concentration of OPT-80(fidaxomicin) [ Time Frame: Day 10-11 ]
- Fecal concentration of OP-1118 [ Time Frame: Day 10-11 ]
- Safety assessed by the incidence of adverse events, vital signs, ECGs and laboratory tests [ Time Frame: Up to 38 days ]

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Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-
Inpatients who have symptoms of CDAD as defined by;
- (1)Diarrhea: with ≥4 unformed bowel movements (or ≥200 mL unformed stool for subjects having rectal collection devices) and
- (2)Presence of either toxin A and/or B of C. difficile in the stool
- Subjects who have not received antibacterials (vancomycin, metronidazole, et.al.) aiming at CDAD treatment before the study
Exclusion Criteria:
- Life-threatening or fulminant CDAD
- Ileus paralytic or toxic megacolon
- Likelihood of death before the completion of study from any cause
- Concurrent use of oral vancomycin, metronidazole, et.al. aiming at the treatment of CDAD
- The anticipated need to continue other antibacterials for a period exceeding seven days from providing the informed consent
- Subjects who in the opinion of the investigator require other drugs to control diarrhea
- Need of change in dosage regimen of opiates during the study period
- Need of change in dosage regimen of probiotic products during the study period
- History/complications of ulcerative colitis or Crohn's disease
- Multiple occurrences of CDAD within the past three months
- Hypersensitivity to vancomycin
- Previous exposure to OPT-80 (fidaxomicin)
- Female patients who are pregnant, breastfeeding or possibly pregnant, or wishing to become pregnant during the course of study
- Participation in other clinical research studies or Post Marketing Clinical Trials utilizing an investigational agent within one month prior to providing the informed consent or within five half-lives of the investigational agent, whichever is longer

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): NCT02179658
Japan | |
Chubu, Japan | |
Chugoku, Japan | |
Hokkaido, Japan | |
Kanto, Japan | |
Kinnki, Japan | |
Kyushu, Japan | |
Touhoku, Japan |
Study Director: | Medical Director | Astellas Pharma Inc |
Responsible Party: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT02179658 History of Changes |
Other Study ID Numbers: |
2819-CL-3002 |
First Posted: | July 2, 2014 Key Record Dates |
Last Update Posted: | September 29, 2016 |
Last Verified: | September 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Keywords provided by Astellas Pharma Inc:
Clostridium Infections Difficile Vancomycin Fidaxomicin |
Additional relevant MeSH terms:
Diarrhea Signs and Symptoms, Digestive Signs and Symptoms |
Vancomycin Anti-Bacterial Agents Anti-Infective Agents |