Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02944448 | A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee | PHASE2 | COMPLETED | 761 | — | — | Sep 1, 2016 | Jun 1, 2017 | Oct 20, 2020 | 35 | United States |
11-point NRS scale where 0 = no pain, and 10= pain as bad as you can imagine
| Arm | Type | Description |
|---|---|---|
| CR845 tablet 1 mg | ACTIVE_COMPARATOR | Dosing twice a day (BID) for a total of 8 weeks, with each dose administered at least 2 hours prior to or after a meal. |
| CR845 tablet 2.5 mg | ACTIVE_COMPARATOR | Dosing twice a day (BID) for a total of 8 weeks, with each dose administered at least 2 hours prior to or after a meal. |
| CR845 tablet 5 mg | ACTIVE_COMPARATOR | Dosing twice a day (BID) for a total of 8 weeks, with each dose administered at least 2 hours prior to or after a meal. |
| Placebo tablet | PLACEBO_COMPARATOR | Dosing twice a day (BID) for a total of 8 weeks, with each dose administered at least 2 hours prior to or after a meal. |
| Name | Type | Description |
|---|---|---|
| CR845 tablet 1 mg | DRUG | CR845 tablets will be provided as 1 mg enteric-coated tablets. All tablets are white in color with no markings and are identical in appearance, regardless of dose and treatment. |
| CR845 tablet 2.5 mg | DRUG | CR845 tablets will be provided as 2.5 mg enteric-coated tablets. All tablets are white in color with no markings and are identical in appearance, regardless of dose and treatment. |
| CR845 tablet 5 mg | DRUG | CR845 tablets will be provided as 5 mg enteric-coated tablets. All tablets are white in color with no markings and are identical in appearance, regardless of dose and treatment. |
| Placebo tablet | DRUG | Placebo tablets will be provided as enteric-coated tablets. All tablets are white in color with no markings and are identical in appearance, regardless of dose and treatment. |
Inclusion Criteria: 1. Voluntarily provides written informed consent to participate in the study prior to any study procedures. 2. Is able to speak, read, and communicate clearly in English or Spanish; is able to understand the study procedures. 3. Male or female ≥ 25 years of age. 4. Body mass ind...