Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CB-183, 315 · 2 trials · 2 indications
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...
CB-183,315 is an investigational small molecule being developed for the treatment of Clostridium difficile infection, a bacterial infection that causes diarrhea and inflammation of the colon. It is being studied in adult patients with this condition.
CB-183,315 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in clinical development for Clostridium difficile infection.
CB-183,315 is in Phase 3 clinical development. It has completed a Phase 2 trial and a Phase 3 trial, both of which were randomized, double-blind, and active-controlled studies in patients with Clostridium difficile infection.
CB-183,315 has been studied in two completed clinical trials. NCT01085591 was a Phase 2 study with 210 participants in the United States and Canada. NCT01598311 was a Phase 3 study with 608 participants, titled "A Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-006)."
CB-183,315 is a small molecule antibiotic that targets Clostridium difficile bacteria. It is being studied for its ability to treat infections caused by this pathogen, which is a common cause of antibiotic-associated diarrhea.
CB-183,315 is not FDA approved. It is an investigational drug that has completed clinical trials but remains in clinical development for the treatment of Clostridium difficile infection.