Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
valdecoxib · 8 trials · 8 indications
| Arm | Type | Description |
|---|---|---|
| Arm 1 | ACTIVE_COMPARATOR | - |
| Arm 2 | ACTIVE_COMPARATOR | - |
| Arm 3 | PLACEBO_COMPARATOR | - |
| Arm 4 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| valdecoxib | DRUG | valdecoxib 10 mg tablet by mouth once daily for 6 weeks |
| naproxen | DRUG | naproxen 500 mg capsule by mouth twice daily for 6 weeks |
| placebo | DRUG | valdecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, placebo BID by mouth on Days 2 to 5. |
| valdecoxib/placebo | DRUG | valdecoxib 40 mg tablet by mouth within 6 hours of surgery followed by placebo 1 to 12 hours after the first dose |
Inclusion Criteria: * Korean outpatients with symptomatic radiologic evidence of OA of the knee (diagnosed according to the modified American College Rheumatology criteria) * Patient's Assessment of Arthritis Pain measurement of at least 40 mm on VAS * Patients had not received any NSAIDs or analge...
Valdecoxib is a small molecule drug developed by Pfizer, Inc. (ticker PFE) as an inhibitor of PTGS2, also known as cyclooxygenase-2. It was studied in Phase 3 clinical trials for pain, including post-surgical pain, osteoarthritis of the knee, and other pain conditions. It is an investigational agent in the trials described here.
Valdecoxib was studied for the treatment of pain, including post-surgical pain following laparoscopic cholecystectomy and bunionectomy surgery, as well as osteoarthritis of the knee. Clinical trials also listed pharyngitis and general osteoarthritis among the conditions evaluated. It is not described as approved for these uses in the trial data summarized here.
Valdecoxib targets PTGS2, the enzyme prostaglandin G/H synthase 2, also called cyclooxygenase-2. It acts as an inhibitor of this target. By inhibiting PTGS2, valdecoxib is designed to reduce prostaglandin production associated with pain and inflammation, which is the basis for its study in pain and osteoarthritis.
Valdecoxib is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the sponsor associated with the Phase 3 clinical trials of valdecoxib listed in the trial record, including studies in post-surgical pain and osteoarthritis of the knee conducted in the United States and South Korea.
Valdecoxib is in Phase 3 development. The trials listed are all Phase 3 studies, and both completed and active trial counts show two completed trials with no active trials. The drug is investigational in this dataset and is not described as FDA approved for any indication.
Valdecoxib has been studied in Phase 3 trials including NCT00683137 for post-surgical pain from bunionectomy, NCT00661635 for post-cholecystectomy pain, NCT00653354 for pain following bunion surgery, and NCT00652808 comparing valdecoxib 10 mg once daily with naproxen 500 mg twice daily in osteoarthritis of the knee. All listed trials are completed.