Pain, Post-surgical Clinical Trial
Official title:
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
| Verified date | December 2018 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 360 |
| Est. completion date | March 2003 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Pfizer Investigational Site | Altoona | Pennsylvania |
| United States | Pfizer Investigational Site | Anaheim | California |
| United States | Pfizer Investigational Site | Chula Vista | California |
| United States | Pfizer Investigational Site | Duncansville | Pennsylvania |
| United States | Pfizer Investigational Site | Johnson City | Tennessee |
| United States | Pfizer Investigational Site | Johnson City | Tennessee |
| United States | Pfizer Investigational Site | Lexington | Kentucky |
| United States | Pfizer Investigational Site | Lexington | Kentucky |
| United States | Pfizer Investigational Site | Lexington | Kentucky |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| United States | Pfizer Investigational Site | Salt Lake City | Utah |
| United States | Pfizer Investigational Site | Salt Lake City | Utah |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | Santa Ana | California |
| United States | Pfizer Investigational Site | Tempe | Arizona |
| United States | Pfizer Investigational Site | Tustin | California |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Summed Pain Intensity Difference (categorical) through 24 hours (SPID 24) | Day 1 | ||
| Primary | Total Pain Relief through 24 hours (TOTPAR 24) | Day 1 | ||
| Primary | Patient's Global Evaluation of Study Medication | Day 1 | ||
| Secondary | time between doses of study medication | Day 1 | ||
| Secondary | Time-specific Pain Intensity Difference (PID) (categorical) | 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours | ||
| Secondary | time-specific pain relief | 2, 4, 6, 8, 10, 12, 16, and 24 hours | ||
| Secondary | time-specific PID (VAS) | 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours | ||
| Secondary | Summed Pain Intensity (SPID)24 (VAS) | 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours | ||
| Secondary | time to rescue medication | 2, 4, 6, 8, 10, 12, 16, and 24 hours | ||
| Secondary | percent of patients who took rescue medication | Day 1 | ||
| Secondary | Patient's Satisfaction Questionnaire | Day 1 |