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

April 21, 2008 updated by: Pfizer

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

490

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35213
        • Pfizer Investigational Site
      • Daphne, Alabama, United States, 36526
        • Pfizer Investigational Site
      • Fairhope, Alabama, United States, 36532
        • Pfizer Investigational Site
      • Mobile, Alabama, United States, 36693
        • Pfizer Investigational Site
      • Mobile, Alabama, United States, 36617
        • Pfizer Investigational Site
      • Sheffield, Alabama, United States, 35660
        • Pfizer Investigational Site
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Pfizer Investigational Site
      • Glendale, Arizona, United States, 85308
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85006
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85023
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85020
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85027
        • Pfizer Investigational Site
      • Tucson, Arizona, United States, 85712
        • Pfizer Investigational Site
      • Tucson, Arizona, United States, 85710
        • Pfizer Investigational Site
      • Tucson, Arizona, United States, 85711
        • Pfizer Investigational Site
    • California
      • Anaheim, California, United States, 92801
        • Pfizer Investigational Site
      • Bakersfield, California, United States, 93309
        • Pfizer Investigational Site
      • Bakersfield, California, United States, 93311
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90057
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90017
        • Pfizer Investigational Site
      • Pasadena, California, United States, 91109
        • Pfizer Investigational Site
      • Sacramento, California, United States, 95817
        • Pfizer Investigational Site
      • San Jose, California, United States, 95124
        • Pfizer Investigational Site
      • Woodland, California, United States, 95695
        • Pfizer Investigational Site
    • Florida
      • Miami, Florida, United States, 33136
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33176
        • Pfizer Investigational Site
      • Pensacola, Florida, United States, 32504
        • Pfizer Investigational Site
    • Georgia
      • Blue Ridge, Georgia, United States, 30513
        • Pfizer Investigational Site
      • Marietta, Georgia, United States, 30060
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Pfizer Investigational Site
      • Maywood, Illinois, United States, 60153
        • Pfizer Investigational Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Pfizer Investigational Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71105
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • Pfizer Investigational Site
      • Germantown, Maryland, United States, 20874
        • Pfizer Investigational Site
      • Rockville, Maryland, United States, 20850
        • Pfizer Investigational Site
      • Silver Spring, Maryland, United States, 20902
        • Pfizer Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Pfizer Investigational Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, United States, 27103-3315
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Pfizer Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19107-4998
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15212
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Pfizer Investigational Site
      • Columbia, South Carolina, United States, 29203
        • Pfizer Investigational Site
      • Columbia, South Carolina, United States, 29209
        • Pfizer Investigational Site
      • Mt. Pleasant, South Carolina, United States, 29464
        • Pfizer Investigational Site
      • North Charleston, South Carolina, United States, 29406
        • Pfizer Investigational Site
      • Summerville, South Carolina, United States, 29485
        • Pfizer Investigational Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Pfizer Investigational Site
      • Kingsport, Tennessee, United States, 37660
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, United States, 77024
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77055
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78224
        • Pfizer Investigational Site
      • Universal City, Texas, United States, 78148
        • Pfizer Investigational Site
    • Utah
      • Sandy, Utah, United States, 84070
        • Pfizer Investigational Site
      • Sandy, Utah, United States, 84094
        • Pfizer Investigational Site
      • West Jordan, Utah, United States, 84088
        • Pfizer Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23517
        • Pfizer Investigational Site
      • Suffolk, Virginia, United States, 23434
        • Pfizer Investigational Site
    • Washington
      • Renton, Washington, United States, 98055
        • Pfizer Investigational Site
      • Renton, Washington, United States, 98058-5010
        • Pfizer Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 2
Drug: 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.
Drug: 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.
Active Comparator: Arm 1
Drug: 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.
Drug: 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.
Placebo Comparator: Arm 3
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Summed Pain Intensity (categorical) through 24 hours (SPI 24)
Time Frame: Day 2 and Day 3
Day 2 and Day 3
Patient's Global Evaluation of Study Medication
Time Frame: Day 2 and Day 3
Day 2 and Day 3

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient's Global Evaluation of Study Medication
Time Frame: Day 4 and Day 5
Day 4 and Day 5
SPI 24 (categorical)
Time Frame: Day 4 and Day 5
Day 4 and Day 5
Time-specific PI (VAS)
Time Frame: Days 2 to 5
Days 2 to 5
Time between doses of study medication
Time Frame: Days 2 to 5
Days 2 to 5
Time to first dose of rescue medication
Time Frame: Days 2 to 5
Days 2 to 5
Percent of patients who took rescue medication on each study day
Time Frame: Days 2 to 5
Days 2 to 5
Amount of rescue medication taken
Time Frame: Days 2 to 5
Days 2 to 5
Worst PI (derived from the mBPI-SF)
Time Frame: Days 2 to 5
Days 2 to 5
Average PI (derived from the mBPI-SF)
Time Frame: Days 2 to 5
Days 2 to 5
Time-specific PI (categorical)
Time Frame: Days 2 to 5
Days 2 to 5
SPI 24 (VAS)
Time Frame: Days 2 to 5
Days 2 to 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Study Completion (Actual)

July 1, 2003

Study Registration Dates

First Submitted

March 31, 2008

First Submitted That Met QC Criteria

April 15, 2008

First Posted (Estimate)

April 18, 2008

Study Record Updates

Last Update Posted (Estimate)

April 23, 2008

Last Update Submitted That Met QC Criteria

April 21, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VALA-0513-145
  • A3471085

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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