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...
Date First Received: March 31, 2008
Last Updated: April 21, 2008
Verified by: Pfizer, March 2008
Clinical Trial Phase: Phase 3 | Start Date: November 2002
Overall Status: Completed
Estimated Enrollment: 490
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Outcome Measures for this Clinical Trial
Primary:
- Patient's Global Evaluation of Study Medication Day 2 and Day 3 No
- 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
- Patient's Global Evaluation of Study Medication Day 4 and Day 5 No
- Time to first dose of rescue medication Days 2 to 5 No
- Percent of patients who took rescue medication on each study day Days 2 to 5 No
- Amount of rescue medication taken Days 2 to 5 No
- Time between doses of study medication Days 2 to 5 No
- Worst PI (derived from the mBPI-SF) Days 2 to 5 No
- Average PI (derived from the mBPI-SF) Days 2 to 5 No
- SPI 24 (categorical) Day 4 and Day 5 No
- Time-specific PI (categorical) Days 2 to 5 No
- SPI 24 (VAS) Days 2 to 5 No
Criteria for Participation in this Clinical Trial
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
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: Pfizer
Pfizer Investigational Site
Sheffield Alabama 35660 United States
Pfizer Investigational Site
Daphne Alabama 36526 United States
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Fairhope Alabama 36532 United States
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Birmingham Alabama 35213 United States
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Mobile Alabama 36617 United States
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Mobile Alabama 36693 United States
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Glendale Arizona 85306 United States
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Glendale Arizona 85308 United States
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Phoenix Arizona 85006 United States
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Phoenix Arizona 85020 United States
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Phoenix Arizona 85023 United States
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Phoenix Arizona 85027 United States
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Tucson Arizona 85711 United States
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Tucson Arizona 85712 United States
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Tucson Arizona 85710 United States
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Anaheim California 92801 United States
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Pasadena California 91109 United States
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Sacramento California 95817 United States
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San Jose California 95124 United States
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Woodland California 95695 United States
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Los Angeles California 90017 United States
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Los Angeles California 90057 United States
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Bakersfield California 93309 United States
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Bakersfield California 93311 United States
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Miami Florida 33176 United States
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Miami Florida 33136 United States
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Pensacola Florida 32504 United States
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Blue Ridge Georgia 30513 United States
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Marietta Georgia 30060 United States
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Maywood Illinois 60153 United States
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Chicago Illinois 60611 United States
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Iowa City Iowa 52242 United States
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Shreveport Louisiana 71105 United States
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Baltimore Maryland 21229 United States
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Germantown Maryland 20874 United States
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Rockville Maryland 20850 United States
Pfizer Investigational Site
Silver Spring Maryland 20902 United States
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Jackson Mississippi 39202 United States
Pfizer Investigational Site
Winston-Salem North Carolina 27103 United States
Pfizer Investigational Site
Winston-Salem North Carolina 27103-3315 United States
Pfizer Investigational Site
Durham North Carolina 27710 United States
Pfizer Investigational Site
Oklahoma City Oklahoma 73104 United States
Pfizer Investigational Site
Allentown Pennsylvania 18103 United States
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Pittsburgh Pennsylvania 15212 United States
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Philadelphia Pennsylvania 19107-4998 United States
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Columbia South Carolina 29203 United States
Pfizer Investigational Site
Columbia South Carolina 29209 United States
Pfizer Investigational Site
Charleston South Carolina 29406 United States
Pfizer Investigational Site
Mt. Pleasant South Carolina 29464 United States
Pfizer Investigational Site
North Charleston South Carolina 29406 United States
Pfizer Investigational Site
Summerville South Carolina 29485 United States
Pfizer Investigational Site
Bristol Tennessee 37620 United States
Pfizer Investigational Site
Kingsport Tennessee 37660 United States
Pfizer Investigational Site
San Antonio Texas 78224 United States
Pfizer Investigational Site
Universal City Texas 78148 United States
Pfizer Investigational Site
Houston Texas 77024 United States
Pfizer Investigational Site
Houston Texas 77055 United States
Pfizer Investigational Site
Sandy Utah 84070 United States
Pfizer Investigational Site
Sandy Utah 84094 United States
Pfizer Investigational Site
West Jordan Utah 84088 United States
Pfizer Investigational Site
Norfolk Virginia 23517 United States
Pfizer Investigational Site
Suffolk Virginia 23434 United States
Pfizer Investigational Site
Renton Washington 98055 United States
Pfizer Investigational Site
Renton Washington 98058-5010 United States
Pfizer Investigational Site
Madison Wisconsin 53792 United States
Overall Clinical Trial Officials and Contacts
Pfizer CT.gov Call Center Study Director Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on July 23, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00661635
Study ID Number: VALA-0513-145
ClinicalTrials.gov Identifier: NCT00661635
Health Authority: United States: Institutional Review Board
To obtain contact information for a study center near you, click here.
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
