Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Parecoxib/Valdecoxib · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| A | PLACEBO_COMPARATOR | - |
| B | EXPERIMENTAL | - |
| C | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| 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: * Patients expected to receive in-hospital pain medication for pain after coronary artery bypass graft surgery for at least 3 full days and pain medication over a 10-day period * New York Heart Association Class I to III or cardiac ejection fraction of at least 35% before surger...
Parecoxib/Valdecoxib is an investigational small molecule being developed for the treatment of pain. It is currently in Phase 3 clinical development. The drug is being studied for its efficacy and safety in managing pain, specifically in patients undergoing coronary artery bypass surgery.
Parecoxib/Valdecoxib is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug's safety and efficacy for pain management.
Parecoxib/Valdecoxib is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug is being evaluated for the treatment of pain.
Parecoxib/Valdecoxib has one completed Phase 3 clinical trial registered under NCT00636064. This randomized, double-blind, placebo-controlled study enrolled 1,671 participants and compared the efficacy and safety of valdecoxib plus parecoxib versus valdecoxib plus placebo for pain after coronary artery bypass surgery.
Parecoxib/Valdecoxib is a combination or comparison involving valdecoxib, but the drug name refers to the study of both agents together. The clinical trial NCT00636064 specifically evaluates valdecoxib plus parecoxib against valdecoxib plus placebo, indicating that parecoxib and valdecoxib are distinct compounds being studied in combination.