Analgesic Efficacy Of Valdecoxib In Patients Following Bunion Surgery
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
2 other identifiers
interventional
360
1 country
21
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2002
Shorter than P25 for phase_3
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
April 1, 2008
CompletedFirst Posted
Study publicly available on registry
April 4, 2008
CompletedDecember 5, 2018
December 1, 2018
April 1, 2008
December 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Summed Pain Intensity Difference (categorical) through 24 hours (SPID 24)
Day 1
Total Pain Relief through 24 hours (TOTPAR 24)
Day 1
Patient's Global Evaluation of Study Medication
Day 1
Secondary Outcomes (8)
time between doses of study medication
Day 1
Time-specific Pain Intensity Difference (PID) (categorical)
0, 2, 4, 6, 8, 10, 12, 16, and 24 hours
time-specific pain relief
2, 4, 6, 8, 10, 12, 16, and 24 hours
time-specific PID (VAS)
0, 2, 4, 6, 8, 10, 12, 16, and 24 hours
Summed Pain Intensity (SPID)24 (VAS)
0, 2, 4, 6, 8, 10, 12, 16, and 24 hours
- +3 more secondary outcomes
Study Arms (3)
Arm 1
ACTIVE COMPARATORArm 2
ACTIVE COMPARATORArm 3
PLACEBO COMPARATORInterventions
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 40 mg tablet by mouth within 6 hours of surgery followed by placebo 1 to 12 hours after the first dose
placebo within 6 hours of surgery followed by placebo 1 to 12 hours after the first dose
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (21)
Pfizer Investigational Site
Phoenix, Arizona, 85015, United States
Pfizer Investigational Site
Phoenix, Arizona, 85016, United States
Pfizer Investigational Site
Phoenix, Arizona, 85020, United States
Pfizer Investigational Site
Phoenix, Arizona, 85032, United States
Pfizer Investigational Site
Tempe, Arizona, 85281, United States
Pfizer Investigational Site
Anaheim, California, 92701, United States
Pfizer Investigational Site
Chula Vista, California, 91911, United States
Pfizer Investigational Site
San Diego, California, 92114, United States
Pfizer Investigational Site
Santa Ana, California, 92701, United States
Pfizer Investigational Site
Tustin, California, 92780, United States
Pfizer Investigational Site
Lexington, Kentucky, 40504, United States
Pfizer Investigational Site
Lexington, Kentucky, 40509, United States
Pfizer Investigational Site
Lexington, Kentucky, 40515, United States
Pfizer Investigational Site
Altoona, Pennsylvania, 16602, United States
Pfizer Investigational Site
Duncansville, Pennsylvania, 16635, United States
Pfizer Investigational Site
Johnson City, Tennessee, 37601, United States
Pfizer Investigational Site
Johnson City, Tennessee, 37604, United States
Pfizer Investigational Site
San Antonio, Texas, 78229, United States
Pfizer Investigational Site
San Antonio, Texas, 78240, United States
Pfizer Investigational Site
Salt Lake City, Utah, 84117, United States
Pfizer Investigational Site
Salt Lake City, Utah, 84123, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 1, 2008
First Posted
April 4, 2008
Study Start
December 1, 2002
Study Completion
March 1, 2003
Last Updated
December 5, 2018
Record last verified: 2018-12