| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01598311 | A Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-006) | PHASE3 | COMPLETED | 608 | — | — | May 16, 2012 | Aug 25, 2015 | Aug 22, 2022 | - | — |
| NCT01085591 | Study of CB-183,315 in Participants With Clostridium Difficile Infection | PHASE2 | COMPLETED | 210 | — | — | Apr 1, 2010 | May 13, 2011 | Sep 11, 2018 | 32 | United States, Canada |
The percentage of participants considered "cured" (i.e., ≤2 loose stools per 24 hour period for at least 2 consecutive days and no need for additional antibiotics during the 3 days following EOT) was determined in the mMITT population. A CDAD diagnosis was defined as: 1) diarrhea with a minimum of 3 unformed bowel movements (UBM) or \>200 mL volume of stool for participants with a collection device (e.g., rectal tube or colostomy bag) over 24 hours; and 2) a positive result for Clostridium difficile toxin by enzyme immunoassay (EIA), polymerase chain reaction (PCR), or a cell culture cytotoxin neutralization assay. Percentages were first stratified according to age (\<75 or ≥75 years) and number of previous CDAD episodes (0 or ≥1) and constructed using Mehrotra-Railkar continuity-corrected minimum-risk stratum weights, and the weighted averages were then derived across strata in order to calculate the adjusted percentage.
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment.
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment.
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.
The number of participants with investigator assessed clinical response of failure or unable to evaluate is presented. Clinical response was determined by the participant's condition on the second day following the last dose of study medication, unless considered a treatment failure. Treatment failures were assessed whenever they occurred and were carried forward to the end-of-treatment (EOT). The information to assess clinical response was collected at any time up to and including Day 19.
| Arm | Type | Description |
|---|---|---|
| CB-183,315 | EXPERIMENTAL | Participants took CB-183,315 250 mg twice daily (b.i.d.) and placebo capsules b.i.d. by mouth for 10 days. |
| Vancomycin | ACTIVE_COMPARATOR | Participants took vancomycin 125 mg four times daily (q.i.d.) by mouth for 10 days. |
| CB-183,315, 125 mg | EXPERIMENTAL | 125 milligrams (mg) CB 183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days. |
| CB-183,315, 250 mg | EXPERIMENTAL | 250 mg CB 183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days. |
| Vancomycin, 125 mg | ACTIVE_COMPARATOR | 125 mg vancomycin administered orally four times a day for 10 days. |
| Name | Type | Description |
|---|---|---|
| CB-183,315 | DRUG | CB-183,315 250 mg white coated tablet over-encapsulated in a size 00 opaque hard gelatin capsule. |
| Vancomycin | DRUG | Vancomycin hydrochloride 125 mg capsule over-encapsulated in size 00 opaque hard gelatin capsule. |
| Placebo | DRUG | Placebo size 00 opaque hard gelatin capsules. |
Inclusion Criteria: * Is able to read and sign a consent form; * Is from ≥18 to \<90 years of age; * Has diarrhea, at least 3 times during one day, or 200 mL or liquid stool if using a rectal device; * Tests positive for Clostridium difficile; * If female, must not be pregnant or nursing and take a...