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Status:

COMPLETED

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

Lead Sponsor:

Pfizer

Conditions:

Pain

Hallux Valgus

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

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 ...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

October 1 2002

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2003

Estimated Enrollment :

450 Patients enrolled

Trial Details

Trial ID

NCT00683137

Start Date

October 1 2002

End Date

February 1 2003

Last Update

May 23 2008

Active Locations (89)

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Page 1 of 23 (89 locations)

1

Pfizer Investigational Site

Chandler, Arizona, United States, 85224

2

Pfizer Investigational Site

Glendale, Arizona, United States, 85302

3

Pfizer Investigational Site

Glendale, Arizona, United States, 85306

4

Pfizer Investigational Site

Mesa, Arizona, United States, 85204