Clinical trial NCT00683137: Analgesic Efficacy And Safety of Valdecoxib For Treatment Of Post-Surgical Pain From Bunionectomy Surgery
Official title: Clinical Protocol for a Multiple Dose Randomized, Double-Blind, Placebo Controlled Study of the Analgesic Efficacy and Safety of Valdecoxib Compared to Placebo in Patients for Treatment of Post-Surgical Pain From Bunionectomy Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Hallux Valgus
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-05-23
Enrollment: 450
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: The study was done to evaluate the pain relief and safety of 2 valdecoxib doses compared to placebo in patients with moderate or severe pain following bunionectomy surgery, and to evaluate the effect of the 2 valdecoxib doses compared to placebo on health outcome measures and on the occurrence of opioid related symptoms.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent an uncomplicated primary unilateral first metatarsal bunionectomy surgery (with or without ipsilateral hammer toe repair) who required open manipulation of bone with periosteal evaluation under general anesthesia (Mayo block)
* Patients with a baseline pain intensity (VAS) of greater than or equal to 45 mm
* Patients with a baseline pain intensity (categorical) of moderate or severe

Exclusion Criteria:

* Patients scheduled to undergo other surgical procedures that would be expected to produce a greater degree of surgical trauma than the orthopedic procedure alone
* Treatment with patient-controlled analgesia (PCA) subsequent to the end of anesthesia
* Long-acting local anesthetics or local anesthetics coadministered with epinephrine injected into the index joint space
* Use of tricyclic antidepressants, tranquilizers, neuroleptics, neuroleptic antiemetics, COX-2 inhibitors, NSAIDs, and corticosteroids
* Use of NSAID or analgesia after midnight the night prior to surgery or unwilling to abstain from NSAIDs or other analgesics, except as specified in the protocol, during the study

Primary outcomes:
measure: Patient's Global Evaluation of Study Medication
timeFrame: Day 2 and Day 3
measure: Summed Pain Intensity (SPI) (categorical) through 24 hours
timeFrame: Day 2 and Day 3
Secondary outcomes:
measure: Health Outcomes Post-Discharge Recovery Experience
timeFrame: Days 2 to 5
measure: adverse events
timeFrame: continuous
measure: Time to first dose of rescue medication (rescue analgesic medication)
timeFrame: Days 2 to 5
measure: SPI 24 (categorical)
timeFrame: Day 4 and Day 5
measure: Time-specific Pain Intensity (PI) (categorical)
timeFrame: Days 2 to 5
measure: SPI 24 (Visual Analog Scale [VAS])
timeFrame: Days 2 to 5
measure: Time-specific PI (VAS)
timeFrame: Days 2 to 5
measure: Patient's Global Evaluation of Study Medication
timeFrame: Day 4 and Day 5
measure: Percent of patients who took rescue medication (rescue analgesic medication)
timeFrame: Days 2 to 5
measure: Worst Pain Intensity (derived from the Modified BPI-Short Form)
timeFrame: Days 2 to 5
measure: Time between doses of study medication
timeFrame: Days 2 to 5
measure: Individual and Composite Pain Interference Score (derived from the modified BPI-Short Form)
timeFrame: Days 2 to 5
measure: Symptom Distress Questionnaire
timeFrame: Days 2 to 5
measure: Average Pain Intensity (derived from the Modified BPI-Short Form)
timeFrame: Days 2 to 5
measure: Amount of rescue medication (rescue analgesic medication) taken
timeFrame: Days 2 to 5
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Mesa
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: 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: National City
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Milford
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Cooper City
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Cutler Ridge
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ft. Lauderdale
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ft. Lauderdale
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Hallandale
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Hollywood
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Hollywood
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: Pfizer Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: Pfizer Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Port Richey
country: United States
facility: Pfizer Investigational Site
state: Florida
city: South Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Spring Hill
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Addison
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Elk Grove Village
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Peoria
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Peoria
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Peoria
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Evansville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Annapolis
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Chester
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Bismarck
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Austintown
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Canfield
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Youngstown
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Youngstown
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Altoona
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Altoona
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Duncansville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Havertown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Media
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Reading
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: State College
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Upland
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Wyomissig
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Greer
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
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: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Holladay
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Layton
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Provo
country: United States
facility: Pfizer Investigational Site
state: Utah
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
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
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Sandy
country: United States
facility: Pfizer Investigational Site
state: Utah
city: St. George
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Tacoma
country: United States
facility: Pfizer Investigational Site
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: