Analgesic Efficacy Of Valdecoxib In Patients Following Bunion Surgery
Phase 3
Completed
- Conditions
- Pain, Post-surgical
- Interventions
- Registration Number
- NCT00653354
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 360
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2 valdecoxib/placebo - Arm 3 placebo - Arm 1 valdecoxib -
- Primary Outcome Measures
Name Time Method Total Pain Relief through 24 hours (TOTPAR 24) Day 1 Patient's Global Evaluation of Study Medication Day 1 Summed Pain Intensity Difference (categorical) through 24 hours (SPID 24) Day 1
- Secondary Outcome Measures
Name Time Method time between doses of study medication Day 1 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 Time-specific Pain Intensity Difference (PID) (categorical) 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 time to rescue medication 2, 4, 6, 8, 10, 12, 16, and 24 hours Patient's Satisfaction Questionnaire Day 1 percent of patients who took rescue medication Day 1
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Salt Lake City, Utah, United States