Analgesic Efficacy Of Valdecoxib In Patients Following Bunion Surgery

Completed · Phase 3 · Has a placebo group

Conditions studied: Pain, Post-surgical

In brief

To assess the analgesic efficacy and general safety of 2 dosing regimens of valdecoxib compared to placebo on the first post-operative day in patients with moderate or severe pain following bunionectomy surgery.

Key facts

Study ID

NCT00653354

Run by

Pfizer

People needed

360

Starts

2002-12-01

Expected to finish

2003-03-01

Last updated by the study team

2018-12-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who underwent an uncomplicated primary unilateral first metatarsal bunionectomy surgery (with or without ipsilateral hammer toe repair) requiring open manipulation of bone with periosteal elevation under regional anesthesia (Mayo block)
• Patients had a Baseline pain intensity of moderate or severe on a categorical scale and ≥45 mm on a VAS

You may not qualify if…

• Patients who were scheduled to undergo other surgical procedures that would be expected to produce a greater degree of surgical trauma than the orthopedic procedure alone
• Patients treated with patient controlled analgesia (PCA) subsequent to the end of anesthesia
• Patients treated with long-acting local anesthetics or local anesthetics coadministered with epinephrine injected into the index joint space
• Patients expected to require analgesics or other agents other than study medication during the 8 hours preceding administration of study medication through the end of the treatment period, that could confound assessment of the analgesic response, specifically excluded were tricyclic antidepressants, tranquilizers, neuroleptics, neuroleptic antiemetics, cyclooxygenase-2 inhibitors, nonsteroidal antiinflammatory drugs, and corticosteroids

Where it is running

• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Tempe, Arizona, United States
• Pfizer Investigational Site — Anaheim, California, United States
• Pfizer Investigational Site — Chula Vista, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — Santa Ana, California, United States
• Pfizer Investigational Site — Tustin, California, United States
• Pfizer Investigational Site — Lexington, Kentucky, United States
• Pfizer Investigational Site — Lexington, Kentucky, United States
• Pfizer Investigational Site — Lexington, Kentucky, United States
• Pfizer Investigational Site — Altoona, Pennsylvania, United States
• Pfizer Investigational Site — Duncansville, Pennsylvania, United States
• Pfizer Investigational Site — Johnson City, Tennessee, United States
• Pfizer Investigational Site — Johnson City, Tennessee, United States
• Pfizer Investigational Site — San Antonio, Texas, United States
• Pfizer Investigational Site — San Antonio, Texas, United States
• Pfizer Investigational Site — Salt Lake City, Utah, United States
• Pfizer Investigational Site — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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