Official Title: “A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Assessment Of The Analgesic Efficacy Of The Dosing Regimen Of Valdecoxib Compared To Placebo Patients In Pain Following Bunionectomy”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: valdecoxib
  • valdecoxib 40 mg tablet by mouth within 6 hours of surgery followed by valdecoxib 20 mg tablet by mouth 1 to 12 hours after the first dose
• Drug: valdecoxib/placebo
  • valdecoxib 40 mg tablet by mouth within 6 hours of surgery followed by placebo 1 to 12 hours after the first dose
• Drug: placebo
  • placebo within 6 hours of surgery followed by placebo 1 to 12 hours after the first dose

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Arm 1
• Active Comparator: Arm 2
• Placebo Comparator: Arm 3

Primary Measures

• Summed Pain Intensity Difference (categorical) through 24 hours (SPID 24)
  • Time Frame: Day 1
    Safety Issue?: No
• Total Pain Relief through 24 hours (TOTPAR 24)
  • Time Frame: Day 1
    Safety Issue?: No
• Patient's Global Evaluation of Study Medication
  • Time Frame: Day 1
    Safety Issue?: No

Secondary Measures

• time between doses of study medication
  • Time Frame: Day 1
    Safety Issue?: No
• Time-specific Pain Intensity Difference (PID) (categorical)
  • Time Frame: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours
    Safety Issue?: No
• time-specific pain relief
  • Time Frame: 2, 4, 6, 8, 10, 12, 16, and 24 hours
    Safety Issue?: No
• time-specific PID (VAS)
  • Time Frame: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours
    Safety Issue?: No
• Summed Pain Intensity (SPID)24 (VAS)
  • Time Frame: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours
    Safety Issue?: No
• time to rescue medication
  • Time Frame: 2, 4, 6, 8, 10, 12, 16, and 24 hours
    Safety Issue?: No
• percent of patients who took rescue medication
  • Time Frame: Day 1
    Safety Issue?: No
• Patient's Satisfaction Questionnaire
  • Time Frame: Day 1
    Safety Issue?: No

Inclusion Criteria:

• 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 Criteria:

• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00653354

Study ID Number: VALA-0513-149

ClinicalTrials.gov Identifier: NCT00653354

Health Authority: United States: Food and Drug Administration

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