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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01511939 | Trial to See if Topical Pennsaid for Knee Pain Affects Coagulation Values in Patients Who Are Also Taking Anticoagulants | PHASE3 | COMPLETED | 22 | — | — | Feb 1, 2012 | May 1, 2013 | Jun 26, 2014 | 1 | United States |
PT will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.
INR will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.
PTT will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.
Platelet Aggregation will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.
| Arm | Type | Description |
|---|---|---|
| Pennsaid, warfarin | OTHER | Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if osteoarthritis pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months |
| Pennsaid, dabigatran | OTHER | Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if osteoarthritis pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months |
| Pennsaid, aspirin and/or clopidogrel | OTHER | Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if osteoarthritis pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months |
| Name | Type | Description |
|---|---|---|
| Pennsaid | DRUG | Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if osteoarthritis pain is present bilaterally) 4 times a day for a 4 week active treatment period. |
Inclusion Criteria: * Male or female adults \> than or equal to 55 * Ambulatory subjects with moderate to severe osteoarthritis (OA) of the knee with symptoms and knee pain for at least 3 months and pain on the majority of days in the last 30 days. * Subjects with bilateral knee OA, the more sympto...