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

NCT ID: NCT00661635

Last Updated: 2008-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

490 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2003-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Laparoscopic Cholecystectomy Pain

Keywords

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Laparoscopic Cholecystectomy Surgery, Acute Pain, Perioperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Arm 1

Group Type ACTIVE_COMPARATOR

valdecoxib

Intervention Type DRUG

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.

Arm 2

Group Type ACTIVE_COMPARATOR

valdecoxib

Intervention Type DRUG

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.

Arm 3

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Birmingham, Alabama, United States

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Daphne, Alabama, United States

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Fairhope, Alabama, United States

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Mobile, Alabama, United States

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Mobile, Alabama, United States

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Sheffield, Alabama, United States

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Glendale, Arizona, United States

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Glendale, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Tucson, Arizona, United States

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Tucson, Arizona, United States

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Anaheim, California, United States

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Bakersfield, California, United States

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Bakersfield, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Pasadena, California, United States

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Sacramento, California, United States

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San Jose, California, United States

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Woodland, California, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Pensacola, Florida, United States

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Blue Ridge, Georgia, United States

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Marietta, Georgia, United States

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Chicago, Illinois, United States

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Maywood, Illinois, United States

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Iowa City, Iowa, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Germantown, Maryland, United States

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Rockville, Maryland, United States

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Silver Spring, Maryland, United States

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Jackson, Mississippi, United States

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Durham, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Oklahoma City, Oklahoma, United States

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Allentown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Columbia, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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North Charleston, South Carolina, United States

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Summerville, South Carolina, United States

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Bristol, Tennessee, United States

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Kingsport, Tennessee, United States

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Houston, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Universal City, Texas, United States

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Sandy City, Utah, United States

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Sandy City, Utah, United States

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West Jordan, Utah, United States

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Norfolk, Virginia, United States

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Suffolk, Virginia, United States

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Renton, Washington, United States

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Renton, Washington, United States

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Madison, Wisconsin, United States

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Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=VALA-0513-145&StudyName=A%20Multiple-dose%2C%20Randomized%2C%20Double-blind%2C%20Placebo-controlled%20Study%20of%20the%20Analgesic%20Efficacy%20and%20Safety%20of%20Valdecoxib%20Compared%20to%20

To obtain contact information for a study center near you, click here.

Other Identifiers

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A3471085

Identifier Type: -

Identifier Source: secondary_id

VALA-0513-145

Identifier Type: -

Identifier Source: org_study_id