- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00653354
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
Intervention / Treatment
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
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Arizona
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Phoenix, Arizona, United States, 85016
- Pfizer Investigational Site
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Phoenix, Arizona, United States, 85032
- Pfizer Investigational Site
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Phoenix, Arizona, United States, 85020
- Pfizer Investigational Site
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Phoenix, Arizona, United States, 85015
- Pfizer Investigational Site
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Tempe, Arizona, United States, 85281
- Pfizer Investigational Site
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California
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Anaheim, California, United States, 92701
- Pfizer Investigational Site
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Chula Vista, California, United States, 91911
- Pfizer Investigational Site
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San Diego, California, United States, 92114
- Pfizer Investigational Site
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Santa Ana, California, United States, 92701
- Pfizer Investigational Site
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Tustin, California, United States, 92780
- Pfizer Investigational Site
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Kentucky
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Lexington, Kentucky, United States, 40504
- Pfizer Investigational Site
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Lexington, Kentucky, United States, 40509
- Pfizer Investigational Site
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Lexington, Kentucky, United States, 40515
- Pfizer Investigational Site
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Pennsylvania
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Altoona, Pennsylvania, United States, 16602
- Pfizer Investigational Site
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Duncansville, Pennsylvania, United States, 16635
- Pfizer Investigational Site
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Tennessee
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Johnson City, Tennessee, United States, 37601
- Pfizer Investigational Site
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Johnson City, Tennessee, United States, 37604
- Pfizer Investigational Site
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Texas
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San Antonio, Texas, United States, 78229
- Pfizer Investigational Site
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San Antonio, Texas, United States, 78240
- Pfizer Investigational Site
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Utah
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Salt Lake City, Utah, United States, 84117
- Pfizer Investigational Site
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Salt Lake City, Utah, United States, 84123
- Pfizer Investigational Site
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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
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Active Comparator: Arm 1
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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
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Placebo Comparator: Arm 3
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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
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Day 1
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Total Pain Relief through 24 hours (TOTPAR 24)
Time Frame: Day 1
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Day 1
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Patient's Global Evaluation of Study Medication
Time Frame: Day 1
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Day 1
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
time between doses of study medication
Time Frame: Day 1
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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
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time-specific pain relief
Time Frame: 2, 4, 6, 8, 10, 12, 16, and 24 hours
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2, 4, 6, 8, 10, 12, 16, and 24 hours
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time-specific PID (VAS)
Time Frame: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours
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0, 2, 4, 6, 8, 10, 12, 16, and 24 hours
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Summed Pain Intensity (SPID)24 (VAS)
Time Frame: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours
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0, 2, 4, 6, 8, 10, 12, 16, and 24 hours
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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
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percent of patients who took rescue medication
Time Frame: Day 1
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Day 1
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Patient's Satisfaction Questionnaire
Time Frame: Day 1
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Day 1
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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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Valdecoxib
Other Study ID Numbers
- VALA-0513-149
- A3471086
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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