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 an investigational small molecule being studied for the management of pain, including acute postsurgical pain following anterior cruciate ligament reconstruction, bunion surgery, and laparoscopic cholecystectomy, as well as for osteoarthritis and pharyngitis. It is in Phase 3 clinical development.
Valdecoxib is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The company is conducting Phase 3 clinical trials to evaluate the drug's efficacy and safety for pain management.
Valdecoxib is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. Multiple Phase 3 trials have been completed to assess its analgesic efficacy and safety in various postsurgical pain settings.
Valdecoxib has been studied in several completed Phase 3 trials, including NCT00650039 for pain after ACL reconstruction, NCT00653354 for pain following bunion surgery, NCT00661635 for post-cholecystectomy pain, and NCT00683137 for pain after bunionectomy. These trials were randomized, double-blind, and placebo-controlled.
Valdecoxib is the generic name for the drug formerly marketed as Bextra. It is a COX-2 selective inhibitor developed by Pfizer. The drug is currently being studied in Phase 3 trials for various pain indications, including postsurgical pain and osteoarthritis.