Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Parecoxib/Valdecoxib · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| A | PLACEBO_COMPARATOR | - |
| B | EXPERIMENTAL | - |
| C | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Parecoxib and placebo | DRUG | - |
| Parecoxib Sodium/Valdecoxib | DRUG | Parecoxib sodium 40 mg intravenous (IV) on the day after surgery (Day 1) following recovery from anesthesia, contingent on an acceptable postoperative status, verification of baseline eligibility, and lack of perioperative complications. A second dose of parecoxib sodium 20 mg IV was administered on Day 1. On the day following surgery, patients received parecoxib 20 mg IV at 8 am and each subsequent dose was administered at 12-hour intervals. After receiving at least 6 doses of IV parecoxib sodium, patients were transitioned to oral valdecoxib 20 mg taken at 12-hour intervals until the total treatment duration of 10 days had been completed. |
| Placebo/Valdecoxib | DRUG | Patients received placebo matched to parecoxib sodium 40 mg IV on Day 1 following recovery from anesthesia, contingent on an acceptable postoperative status, verification of baseline eligibility, and lack of perioperative complications. A second dose of placebo matched to parecoxib sodium 20 mg IV was administered on Day 1. On the day following surgery, patients received placebo matched to parecoxib sodium 20 mg IV at 8 am and each subsequent dose was administered at 12-hour intervals. After receiving at least 6 doses of IV placebo, patients were transitioned to oral valdecoxib 20 mg taken at 12-hour intervals until the total treatment duration of 10 days had been completed. |
| Placebo/Placebo | OTHER | Patients received placebo matched to parecoxib sodium 40 mg IV on Day 1 following recovery from anesthesia, contingent on an acceptable postoperative status, verification of baseline eligibility, and lack of perioperative complications. A second dose of placebo matched to parecoxib sodium 20 mg IV was administered on Day 1. On the day following surgery, patients received placebo matched to parecoxib sodium 20 mg IV at 8 am and each subsequent dose was administered at 12-hour intervals. After receiving at least 6 doses of IV placebo, patients were transitioned to oral placebo matched to valdecoxib 20 mg taken at 12-hour intervals until the total treatment duration of 10 days had been completed. |
Inclusion Criteria: * Undergo gynecological or orthopedic surgery under epidural anesthesia Exclusion Criteria: * A previous history of intolerance or hypersensitivity to any NSAID, cyclooxygenase-2 selective inhibitors, sulphonamides, or any of the excipients of parecoxib.
Parecoxib/Valdecoxib is used for the treatment of pain, including postoperative pain. It is a small molecule being developed by Pfizer, Inc. for pain management, with clinical study experience in patients recovering from coronary artery bypass surgery and other surgical procedures.
Parecoxib/Valdecoxib targets PTGS2, also known as cyclooxygenase-2. It is an inhibitor of this enzyme. By inhibiting PTGS2, the drug is designed to reduce pain and inflammation. This mechanism underlies its development for pain and postoperative pain indications.
Parecoxib/Valdecoxib is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the company responsible for the clinical development of this small molecule pain therapy.
Parecoxib/Valdecoxib is in Phase 3 clinical development. It is an investigational therapy and has not been approved by the FDA. The program has completed Phase 3 trials, and no trials are currently active.
Parecoxib/Valdecoxib has been studied in two completed Phase 3 trials. NCT00636064 compared valdecoxib plus parecoxib versus valdecoxib plus placebo for pain after coronary artery bypass surgery, enrolling 1,671 patients. NCT00143169 evaluated the morphine-sparing effect and safety of intravenous parecoxib for postoperative pain in 220 patients in China.