Status:
COMPLETED
Analgesic Efficacy Of Valdecoxib In Patients Following Bunion Surgery
Lead Sponsor:
Pfizer
Conditions:
Pain, Post-surgical
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 bunionecto...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2003
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00653354
Start Date
December 1 2002
End Date
March 1 2003
Last Update
December 5 2018
Active Locations (21)
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1
Pfizer Investigational Site
Phoenix, Arizona, United States, 85015
2
Pfizer Investigational Site
Phoenix, Arizona, United States, 85016
3
Pfizer Investigational Site
Phoenix, Arizona, United States, 85020
4
Pfizer Investigational Site
Phoenix, Arizona, United States, 85032