Clinical trial NCT00661635: A Randomized, Double-Blind Study of the Efficacy and Safety of Valdecoxib Compared to Placebo for Treatment of Post- Cholecystectomy Surgery Pain
Official title: 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 Laparoscopic Cholecystectomy Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Laparoscopic Cholecystectomy
Pain
Keywords: Laparoscopic Cholecystectomy Surgery, Acute Pain, Perioperative Pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-18
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the analgesic efficacy, general safety, and effects on health outcome measures and opioid-related symptoms of 2 valdecoxib dosing regimens compared with placebo in patients with moderate or severe pain following laparoscopic cholecystectomy surgery.


Eligibility criteria: Inclusion Criteria:

* Patients had required an elective, non-urgent laparoscopic cholecystectomy, as an outpatient procedure, with ASA Class I-III, with a Baseline Pain Intensity of moderate or severe on a categorical scale and ≥45 mm on a VAS (100 mm)
* Patients were able to get their first dose of study medication within 8 hours after the end of surgery

Exclusion Criteria:

* Patients could not undergo procedures expected to produce a greater degree of surgical trauma than the laparoscopic cholecystectomy alone, nor have acute pre-operative pain (other than biliary colic) nor chronic pain conditions, nor uncontrolled chronic conditions, nor cancer, nor a laboratory abnormality that the investigator considered to contraindicate study participation
* Patient had any cognitive impairment that would, in the investigator's opinion, preclude study participation or compliance with protocol mandated procedures
* Patient had a history of known alcohol, analgesic, or narcotic substance abuse within the one year prior to Screening
* Patient had any laboratory abnormality at screening, that, in the opinion of the investigator, is not due to the condition requiring surgery and is not expected to resolve post-surgery, and would, therefore, contraindicate study participation

Primary outcomes:
measure: Patient's Global Evaluation of Study Medication
timeFrame: Day 2 and Day 3
measure: Summed Pain Intensity (categorical) through 24 hours (SPI 24)
timeFrame: Day 2 and Day 3
Secondary outcomes:
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: Time to first dose of rescue medication
timeFrame: Days 2 to 5
measure: Percent of patients who took rescue medication on each study day
timeFrame: Days 2 to 5
measure: Amount of rescue medication taken
timeFrame: Days 2 to 5
measure: Time between doses of study medication
timeFrame: Days 2 to 5
measure: Worst PI (derived from the mBPI-SF)
timeFrame: Days 2 to 5
measure: Average PI (derived from the mBPI-SF)
timeFrame: Days 2 to 5
measure: SPI 24 (categorical)
timeFrame: Day 4 and Day 5
measure: Time-specific PI (categorical)
timeFrame: Days 2 to 5
measure: SPI 24 (VAS)
timeFrame: Days 2 to 5
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Daphne
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Fairhope
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Mobile
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Mobile
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Sheffield
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Glendale
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: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Anaheim
country: United States
facility: Pfizer Investigational Site
state: California
city: Bakersfield
country: United States
facility: Pfizer Investigational Site
state: California
city: Bakersfield
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Pasadena
country: United States
facility: Pfizer Investigational Site
state: California
city: Sacramento
country: United States
facility: Pfizer Investigational Site
state: California
city: San Jose
country: United States
facility: Pfizer Investigational Site
state: California
city: Woodland
country: United States
facility: Pfizer Investigational Site
state: California
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pensacola
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Blue Ridge
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Marietta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Maywood
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Iowa City
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Shreveport
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Germantown
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Rockville
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Silver Spring
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Jackson
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Allentown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Mt. Pleasant
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: North Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Summerville
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Bristol
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Kingsport
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Universal City
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Sandy
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Sandy
country: United States
facility: Pfizer Investigational Site
state: Utah
city: West Jordan
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Norfolk
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Suffolk
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Renton
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Renton
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Madison
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: