Analgesic Efficacy Of Valdecoxib In Patients Following Bunion Surgery

December 3, 2018 updated by: Pfizer

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 Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85032
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85020
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85015
        • Pfizer Investigational Site
      • Tempe, Arizona, United States, 85281
        • Pfizer Investigational Site
    • California
      • Anaheim, California, United States, 92701
        • Pfizer Investigational Site
      • Chula Vista, California, United States, 91911
        • Pfizer Investigational Site
      • San Diego, California, United States, 92114
        • Pfizer Investigational Site
      • Santa Ana, California, United States, 92701
        • Pfizer Investigational Site
      • Tustin, California, United States, 92780
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Pfizer Investigational Site
      • Lexington, Kentucky, United States, 40509
        • Pfizer Investigational Site
      • Lexington, Kentucky, United States, 40515
        • Pfizer Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Pfizer Investigational Site
      • Duncansville, Pennsylvania, United States, 16635
        • Pfizer Investigational Site
    • Tennessee
      • Johnson City, Tennessee, United States, 37601
        • Pfizer Investigational Site
      • Johnson City, Tennessee, United States, 37604
        • Pfizer Investigational Site
    • Texas
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78240
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84117
        • Pfizer Investigational Site
      • Salt Lake City, Utah, United States, 84123
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 2
valdecoxib 40 mg tablet by mouth within 6 hours of surgery followed by placebo 1 to 12 hours after the first dose
Active Comparator: Arm 1
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
Placebo Comparator: Arm 3
placebo within 6 hours of surgery followed by placebo 1 to 12 hours after the first dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Summed Pain Intensity Difference (categorical) through 24 hours (SPID 24)
Time Frame: Day 1
Day 1
Total Pain Relief through 24 hours (TOTPAR 24)
Time Frame: Day 1
Day 1
Patient's Global Evaluation of Study Medication
Time Frame: Day 1
Day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
time between doses of study medication
Time Frame: Day 1
Day 1
Time-specific Pain Intensity Difference (PID) (categorical)
Time Frame: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours
0, 2, 4, 6, 8, 10, 12, 16, and 24 hours
time-specific pain relief
Time Frame: 2, 4, 6, 8, 10, 12, 16, and 24 hours
2, 4, 6, 8, 10, 12, 16, and 24 hours
time-specific PID (VAS)
Time Frame: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours
0, 2, 4, 6, 8, 10, 12, 16, and 24 hours
Summed Pain Intensity (SPID)24 (VAS)
Time Frame: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours
0, 2, 4, 6, 8, 10, 12, 16, and 24 hours
time to rescue medication
Time Frame: 2, 4, 6, 8, 10, 12, 16, and 24 hours
2, 4, 6, 8, 10, 12, 16, and 24 hours
percent of patients who took rescue medication
Time Frame: Day 1
Day 1
Patient's Satisfaction Questionnaire
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Study Completion (Actual)

March 1, 2003

Study Registration Dates

First Submitted

April 1, 2008

First Submitted That Met QC Criteria

April 3, 2008

First Posted (Estimate)

April 4, 2008

Study Record Updates

Last Update Posted (Actual)

December 5, 2018

Last Update Submitted That Met QC Criteria

December 3, 2018

Last Verified

December 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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