Clinical trial NCT00653354: Analgesic Efficacy Of Valdecoxib In Patients Following Bunion Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Post-surgical
Keywords: hallux valgus
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-04
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Summed Pain Intensity Difference (categorical) through 24 hours (SPID 24)
timeFrame: Day 1
measure: Total Pain Relief through 24 hours (TOTPAR 24)
timeFrame: Day 1
measure: Patient's Global Evaluation of Study Medication
timeFrame: Day 1
Secondary outcomes:
measure: time between doses of study medication
timeFrame: Day 1
measure: Time-specific Pain Intensity Difference (PID) (categorical)
timeFrame: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours
measure: time-specific pain relief
timeFrame: 2, 4, 6, 8, 10, 12, 16, and 24 hours
measure: time-specific PID (VAS)
timeFrame: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours
measure: Summed Pain Intensity (SPID)24 (VAS)
timeFrame: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours
measure: time to rescue medication
timeFrame: 2, 4, 6, 8, 10, 12, 16, and 24 hours
measure: percent of patients who took rescue medication
timeFrame: Day 1
measure: Patient's Satisfaction Questionnaire
timeFrame: Day 1
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tempe
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Anaheim
country: United States
facility: Pfizer Investigational Site
state: California
city: Chula Vista
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Ana
country: United States
facility: Pfizer Investigational Site
state: California
city: Tustin
country: United States
facility: Pfizer Investigational Site
state: California
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Altoona
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Duncansville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Johnson City
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Johnson City
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: