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Completed

NCT Number: NCT00653354

Analgesic Efficacy Of Valdecoxib In Patients Following Bunion Surgery

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.

Completed

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Key information

Conditions

Pain, Post-surgical Foot Deformities Hallux Valgus Musculoskeletal Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

valdecoxib

Drug

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

valdecoxib/placebo

Drug

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

Placebo

Drug

placebo within 6 hours of surgery followed by placebo 1 to 12 hours after the first dose

Primary outcomes

  1. Summed Pain Intensity Difference (categorical) through 24 hours (SPID 24)

    Time frame: Day 1

  2. Total Pain Relief through 24 hours (TOTPAR 24)

    Time frame: Day 1

  3. Patient's Global Evaluation of Study Medication

    Time frame: Day 1

Secondary outcomes

  1. time between doses of study medication

    Time frame: Day 1

  2. Time-specific Pain Intensity Difference (PID) (categorical)

    Time frame: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours

  3. time-specific pain relief

    Time frame: 2, 4, 6, 8, 10, 12, 16, and 24 hours

  4. time-specific PID (VAS)

    Time frame: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours

  5. Summed Pain Intensity (SPID)24 (VAS)

    Time frame: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours

  6. time to rescue medication

    Time frame: 2, 4, 6, 8, 10, 12, 16, and 24 hours

  7. percent of patients who took rescue medication

    Time frame: Day 1

  8. Patient's Satisfaction Questionnaire

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2002
Study completion
2003
First posted
Apr 4, 2008
Registry last updated
Dec 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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