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A Multicentre, Double-Blind, Double-Dummy, Randomised Study of the Analgesic Efficacy and Safety of Valdecoxib Compared to Diclofenac Sodium in Patients Undergoing Knee Arthroscopy for Anterior Cruciate Ligament (ACL) Reconstruction

NCT ID: NCT00650598

Last Updated: 2008-10-08

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

PHASE4

Total Enrollment

328 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2004-08-31

Brief Summary

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To demonstrate non-inferiority of valdecoxib 20 mg twice daily (BID) (with an initial loading dose of 40 mg followed by a second dose of 20 mg on the first day only) with diclofenac sodium delayed release 75 mg BID in analgesic efficacy, in subjects undergoing knee arthroscopy procedure for anterior cruciate ligament (ACL) reconstruction, when administered for 6 (±1) days.

Detailed Description

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Conditions

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Pain, Postoperative

Keywords

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anterior cruciate ligament, arthroscopy, knee, post-surgical pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Group Type ACTIVE_COMPARATOR

valdecoxib

Intervention Type DRUG

valdecoxib 40 mg (two 20-mg tablets) loading dose by mouth on Day 1 followed by 20 mg twice daily (BID) on Days 2-6

Arm 2

Group Type ACTIVE_COMPARATOR

diclofenac

Intervention Type DRUG

diclofenac sodium delayed release tablets 75 mg by mouth twice daily (BID) for 6 days

Interventions

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valdecoxib

valdecoxib 40 mg (two 20-mg tablets) loading dose by mouth on Day 1 followed by 20 mg twice daily (BID) on Days 2-6

Intervention Type DRUG

diclofenac

diclofenac sodium delayed release tablets 75 mg by mouth twice daily (BID) for 6 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who had undergone an uncomplicated ACL reconstruction procedure and were in satisfactory health were included in the study
* In addition, they needed to have a baseline pain intensity of ≥ 50 mm on the VAS and "moderate to severe" pain on the categorical scale within 8 hours of the completion of the surgical procedure to be included

Exclusion Criteria

* Patient was scheduled to undergo any other surgical procedure, along with the orthopedic procedure, that was expected to produce a greater degree of surgical trauma than the orthopedic procedure alone
* The patient was undergoing bilateral knee arthroscopy
* The patient used conventional NSAIDs, COX-2 inhibitors, or Tramadol during the 6 hours preceding surgery, during surgery or subsequent to the end of surgery, until randomization
* The patient received oxaprozin or piroxicam within one week prior to randomization
* The patient was required to take muscle relaxants, tricyclic antidepressants, tranquilizers, sedatives, hypnotics and neuroleptics, in the post operative period after the patient was randomized into the study
* The patient had been treated with patient controlled analgesia subsequent to the end of the surgical procedure
Minimum Eligible Age

18 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

Adelaide, South Australia, Australia

Site Status

Pfizer Investigational Site

Hong Kong, , Hong Kong

Site Status

Pfizer Investigational Site

Shatin, New Territories, , Hong Kong

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Pfizer Investigational Site

Cheras, Kuala Lumpur, Malaysia

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Pfizer Investigational Site

Kuala Lumpur, Kuala Lumpur, Malaysia

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Pfizer Investigational Site

Kuala Lumpur, Kuala Lumpur, Malaysia

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Pfizer Investigational Site

Auckland, , New Zealand

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Pfizer Investigational Site

Christchurch, , New Zealand

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Pfizer Investigational Site

Wellington, , New Zealand

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Pfizer Investigational Site

Manila, , Philippines

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Pfizer Investigational Site

Quezon, , Philippines

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Pfizer Investigational Site

Quezon City, , Philippines

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Pfizer Investigational Site

Singapore, , Singapore

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Pfizer Investigational Site

Seoul, , South Korea

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Pfizer Investigational Site

Seoul, , South Korea

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Pfizer Investigational Site

Seoul, , South Korea

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Pfizer Investigational Site

Seoul, , South Korea

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Pfizer Investigational Site

Kaohsiung City, , Taiwan

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Pfizer Investigational Site

Keelung, , Taiwan

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Pfizer Investigational Site

Taipei, , Taiwan

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Pfizer Investigational Site

Bangkok, , Thailand

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Pfizer Investigational Site

Bangkok, , Thailand

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Pfizer Investigational Site

Bangkok, , Thailand

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Pfizer Investigational Site

Bangkok, , Thailand

Site Status

Pfizer Investigational Site

, ,

Site Status

Countries

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Australia Hong Kong Malaysia New Zealand Philippines Singapore South Korea Taiwan Thailand

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3471039&StudyName=A%20Multicentre%2C%20Double-Blind%2C%20Double-Dummy%2C%20Randomised%20Study%20of%20the%20Analgesic%20Efficacy%20and%20Safety%20of%20Valdecoxib%20Compared%20to%20Diclofenac%20

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

Other Identifiers

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A3471039

Identifier Type: -

Identifier Source: org_study_id