Analgesic Efficacy And Safety of Valdecoxib For Treatment Of Post-Surgical Pain From Bunionectomy Surgery

Completed · Phase 3 · Has a placebo group

Conditions studied: Pain, Hallux Valgus

In brief

The study was done to evaluate the pain relief and safety of 2 valdecoxib doses compared to placebo in patients with moderate or severe pain following bunionectomy surgery, and to evaluate the effect of the 2 valdecoxib doses compared to placebo on health outcome measures and on the occurrence of opioid related symptoms.

Key facts

Study ID

NCT00683137

Run by

Pfizer

People needed

450

Starts

2002-10-01

Expected to finish

2003-02-01

Last updated by the study team

2008-05-23

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) who required open manipulation of bone with periosteal evaluation under general anesthesia (Mayo block)
• Patients with a baseline pain intensity (VAS) of greater than or equal to 45 mm
• Patients with a baseline pain intensity (categorical) of moderate or severe

You may not qualify if…

• Patients scheduled to undergo other surgical procedures that would be expected to produce a greater degree of surgical trauma than the orthopedic procedure alone
• Treatment with patient-controlled analgesia (PCA) subsequent to the end of anesthesia
• Long-acting local anesthetics or local anesthetics coadministered with epinephrine injected into the index joint space
• Use of tricyclic antidepressants, tranquilizers, neuroleptics, neuroleptic antiemetics, COX-2 inhibitors, NSAIDs, and corticosteroids
• Use of NSAID or analgesia after midnight the night prior to surgery or unwilling to abstain from NSAIDs or other analgesics, except as specified in the protocol, during the study

Where it is running

• Pfizer Investigational Site — Glendale, Arizona, United States
• Pfizer Investigational Site — Glendale, Arizona, United States
• Pfizer Investigational Site — Mesa, 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 — Phoenix, Arizona, United States
• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — National City, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — Milford, Connecticut, United States
• Pfizer Investigational Site — New Haven, Connecticut, United States
• Pfizer Investigational Site — New Haven, Connecticut, United States
• Pfizer Investigational Site — Cooper City, Florida, United States
• Pfizer Investigational Site — Cutler Ridge, Florida, United States
• Pfizer Investigational Site — Fort Lauderdale, Florida, United States
• Pfizer Investigational Site — Fort Lauderdale, Florida, United States
• Pfizer Investigational Site — Hallandale, Florida, United States
• Pfizer Investigational Site — Hollywood, Florida, United States
• Pfizer Investigational Site — Hollywood, Florida, United States
• Pfizer Investigational Site — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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