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NCT00661635 Clinical Trial

A Randomized, Double-Blind Study of the Efficacy and Safety of Valdecoxib Compared to Placebo for Treatment of Post- Cholecystectomy Surgery Pain

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00661635
Other study ID # VALA-0513-145
Secondary ID A3471085
Status Completed
Phase Phase 3
First received March 31, 2008
Last updated April 21, 2008
Start date November 2002
Est. completion date July 2003

Study information
Verified date March 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 490
Est. completion date July 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• placebo
valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, placebo twice daily (BID) on Days 2 to 5
• valdecoxib
valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, valdecoxib 20 mg once daily (QD)on Days 2 to 5.
• valdecoxib
valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, valdecoxib 20 mg twice daily (BID) on Days 2 to 5.

Locations
Country Name City State
United States Pfizer Investigational Site Allentown Pennsylvania
United States Pfizer Investigational Site Anaheim California
United States Pfizer Investigational Site Bakersfield California
United States Pfizer Investigational Site Bakersfield California
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Blue Ridge Georgia
United States Pfizer Investigational Site Bristol Tennessee
United States Pfizer Investigational Site Charleston South Carolina
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Columbia South Carolina
United States Pfizer Investigational Site Columbia South Carolina
United States Pfizer Investigational Site Daphne Alabama
United States Pfizer Investigational Site Durham North Carolina
United States Pfizer Investigational Site Fairhope Alabama
United States Pfizer Investigational Site Germantown Maryland
United States Pfizer Investigational Site Glendale Arizona
United States Pfizer Investigational Site Glendale Arizona
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Iowa City Iowa
United States Pfizer Investigational Site Jackson Mississippi
United States Pfizer Investigational Site Kingsport Tennessee
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Madison Wisconsin
United States Pfizer Investigational Site Marietta Georgia
United States Pfizer Investigational Site Maywood Illinois
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Mobile Alabama
United States Pfizer Investigational Site Mobile Alabama
United States Pfizer Investigational Site Mt. Pleasant South Carolina
United States Pfizer Investigational Site Norfolk Virginia
United States Pfizer Investigational Site North Charleston South Carolina
United States Pfizer Investigational Site Oklahoma City Oklahoma
United States Pfizer Investigational Site Pasadena California
United States Pfizer Investigational Site Pensacola Florida
United States Pfizer Investigational Site Philadelphia Pennsylvania
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 Pittsburgh Pennsylvania
United States Pfizer Investigational Site Renton Washington
United States Pfizer Investigational Site Renton Washington
United States Pfizer Investigational Site Rockville Maryland
United States Pfizer Investigational Site Sacramento California
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Jose California
United States Pfizer Investigational Site Sandy Utah
United States Pfizer Investigational Site Sandy Utah
United States Pfizer Investigational Site Sheffield Alabama
United States Pfizer Investigational Site Shreveport Louisiana
United States Pfizer Investigational Site Silver Spring Maryland
United States Pfizer Investigational Site Suffolk Virginia
United States Pfizer Investigational Site Summerville South Carolina
United States Pfizer Investigational Site Tucson Arizona
United States Pfizer Investigational Site Tucson Arizona
United States Pfizer Investigational Site Tucson Arizona
United States Pfizer Investigational Site Universal City Texas
United States Pfizer Investigational Site West Jordan Utah
United States Pfizer Investigational Site Winston-Salem North Carolina
United States Pfizer Investigational Site Winston-Salem North Carolina
United States Pfizer Investigational Site Woodland California

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patient's Global Evaluation of Study Medication Day 2 and Day 3 No
Primary Summed Pain Intensity (categorical) through 24 hours (SPI 24) Day 2 and Day 3 No
Secondary Time-specific PI (VAS) Days 2 to 5 No
Secondary Patient's Global Evaluation of Study Medication Day 4 and Day 5 No
Secondary Time to first dose of rescue medication Days 2 to 5 No
Secondary Percent of patients who took rescue medication on each study day Days 2 to 5 No
Secondary Amount of rescue medication taken Days 2 to 5 No
Secondary Time between doses of study medication Days 2 to 5 No
Secondary Worst PI (derived from the mBPI-SF) Days 2 to 5 No
Secondary Average PI (derived from the mBPI-SF) Days 2 to 5 No
Secondary SPI 24 (categorical) Day 4 and Day 5 No
Secondary Time-specific PI (categorical) Days 2 to 5 No
Secondary SPI 24 (VAS) Days 2 to 5 No
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