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NCT01085591 · ClinicalTrials.gov registry record · Phase 2
Study of CB-183,315 in Participants With Clostridium Difficile Infection
A Phase 2 study of Diarrhea and Clostridium Difficile Infection, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- Completed
- Registry status
- Phase 2
- Development phase
- 210
- Enrollment target
- 20
- Study locations
NCT01085591: Completed Phase 2 study of Diarrhea and Clostridium Difficile Infection, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
NCT01085591 is a Phase 2 study of Diarrhea and Clostridium Difficile Infection that has completed, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). The registered enrollment target is 210 participants, above the 148-participant average among 24 other Diarrhea trials with a reported enrollment target (42% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01085591, a Phase 2 study of Diarrhea and Clostridium Difficile Infection, has completed, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 210 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a randomized, double-blind, single-placebo, active-controlled, dose ranging parallel group design with 3 arms. Two dose regimens of CB-183,315 dosed twice daily will be compared with the active comparator oral vancomycin (125 milligrams (mg ) four times daily). Participants with diarrhea at risk for Clostridium difficile infection (CDI) \[for example, received prior or concomitant antibiotic(s)\] will be identified and tested for C. difficile toxin in stool using an enzyme immunoassay (EIA), or polymerase chain reaction (PCR) per the usual standard of care. Eligible participants will be consented, undergo baseline evaluations, and will be randomized in a blinded fashion to one of 3 treatment arms. Participants will be randomized to receive either 125 mg CB-183,315 twice daily alternating with placebo tablets twice daily, 250 mg CB-183,315 twice daily alternating with placebo tablets twice daily or 125 mg oral vancomycin four times dailyover a period of 10 days in a 1:1:1 fashion.
Primary Outcome
The number of participants with an Investigator-assessed clinical response of cure is presented. The information to assess clinical response was collected at any time up to and including Day 19.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Vancomycin
- DRUG CB-183,315
Study Locations (20)
Georgia
- Atlanta Institute for Medical Research, Inc - Decatur
- Gastrointestinal Specialists of Georgia PC - Marietta
- Wellstar Infectious Disease - Marietta
Michigan
- Henry Ford Health System - Detroit
- - Keego Harbor
- William Beaumont Hospital - Royal Oak
District of Columbia
- Providence Hospital Clinical Research Center - Washington D.C.
- Washington Hospital Center - Washington D.C.
Florida
- Central Florida Internists - Saint Cloud
Idaho
- Idaho Falls Infectious Disease, PLLC - Idaho City
Illinois
- University of Chicago - Chicago
Kansas
- University of Kansas Medical Center - Kansas City
Louisiana
- Ochsner Clinic Foundation - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2010-04-01 |
| Est. Completion | 2011-05-13 |
| Phase | Phase 2 |
Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)42 total trials
What the finished NCT01085591 record still lists
NCT01085591 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, above the 148-participant average among 24 other Diarrhea trials with a reported enrollment target (42% higher).
The record links to 2 conditions, with Diarrhea appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01085591 names 20 study sites across 15 states, led by Georgia, Michigan, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT01085591 about?
NCT01085591 is a clinical study titled "Study of CB-183,315 in Participants With Clostridium Difficile Infection". This is a randomized, double-blind, single-placebo, active-controlled, dose ranging parallel group design with 3 arms. Two dose regimens of CB-183,315 dosed twice daily will be compared with the active comparator oral vancomycin (125 milligrams (mg ) four times daily). Participants with diarrhea at ...
What is the current status of trial NCT01085591?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 210 participants. The study started on 2010-04-01. Estimated completion is 2011-05-13.
What conditions does trial NCT01085591 study?
This clinical trial studies the following conditions: Diarrhea, Clostridium Difficile Infection.
What interventions are being tested in trial NCT01085591?
The interventions under investigation include: Placebo (DRUG), Vancomycin (DRUG), CB-183,315 (DRUG).
Who is sponsoring clinical trial NCT01085591?
This trial is sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 42 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01085591 being conducted?
This trial has 20 study locations across District of Columbia, Florida, Georgia, Idaho, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01085591's enrollment target sits among peer trials
210 6th of 24 higher than 19 of 24 other Diarrhea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diarrhea trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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