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Completed

NCT Number: NCT00683137

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

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.

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Key information

Conditions

Pain Foot Deformities Hallux Valgus Musculoskeletal Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Chandler, 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) 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 criteria

  • 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

Treatment and study plan

valdecoxib

Drug

valdecoxib 40 mg tablet by mouth followed by a valdecoxib 20 mg tablet by mouth after 1 to 12 hours of the initial dose on Day 1 then a valdecoxib 20 mg tablet by mouth once daily on Days 2 through 5

valdecoxib/placebo

Drug

valdecoxib 40 mg tablet by mouth followed by a valdecoxib 20 mg tablet by mouth after 1 to 12 hours of the initial dose on Day 1 then placebo on Days 2 through 5

Primary outcomes

  1. Patient's Global Evaluation of Study Medication

    Time frame: Day 2 and Day 3

  2. Summed Pain Intensity (SPI) (categorical) through 24 hours

    Time frame: Day 2 and Day 3

Secondary outcomes

  1. Health Outcomes Post-Discharge Recovery Experience

    Time frame: Days 2 to 5

  2. adverse events

    Time frame: continuous

  3. Time to first dose of rescue medication (rescue analgesic medication)

    Time frame: Days 2 to 5

  4. SPI 24 (categorical)

    Time frame: Day 4 and Day 5

  5. Time-specific Pain Intensity (PI) (categorical)

    Time frame: Days 2 to 5

  6. SPI 24 (Visual Analog Scale [VAS])

    Time frame: Days 2 to 5

  7. Time-specific PI (VAS)

    Time frame: Days 2 to 5

  8. Patient's Global Evaluation of Study Medication

    Time frame: Day 4 and Day 5

  9. Percent of patients who took rescue medication (rescue analgesic medication)

    Time frame: Days 2 to 5

  10. Worst Pain Intensity (derived from the Modified BPI-Short Form)

    Time frame: Days 2 to 5

  11. Time between doses of study medication

    Time frame: Days 2 to 5

  12. Individual and Composite Pain Interference Score (derived from the modified BPI-Short Form)

    Time frame: Days 2 to 5

  13. Symptom Distress Questionnaire

    Time frame: Days 2 to 5

  14. Average Pain Intensity (derived from the Modified BPI-Short Form)

    Time frame: Days 2 to 5

  15. Amount of rescue medication (rescue analgesic medication) taken

    Time frame: Days 2 to 5

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Clinical Protocol for a Multiple Dose Randomized, Double-Blind, Placebo Controlled Study of the Analgesic Efficacy and Safety of Valdecoxib Compared to Placebo in Patients for Treatment of Post-Surgical Pain From Bunionectomy Surgery

Important dates

Study start
2002
Study completion
2003
First posted
May 23, 2008
Registry last updated
May 23, 2008

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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