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Double-Blind, Double Dummy, Randomized Comparison Study to Evaluate the Efficacy and Safety of Valdecoxib 10 mg Once Daily and Naproxen 500 mg Twice Daily in Treating the Signs and Symptoms of Osteoarthritis of the Knee

NCT ID: NCT00652808

Last Updated: 2008-04-10

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

265 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2004-09-30

Brief Summary

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This study was performed to demonstrate that treatment with valdecoxib 10 mg daily (QD) was at least as effective as with naproxen 500 mg twice daily (BID), a standard non-steroidal anti-inflammatory drug (NSAID), when taken for 6 weeks in Korean subjects with symptomatic osteoarthritis (OA) of the knee. Secondary objectives were to assess the overall safety and tolerability of valdecoxib 10 mg QD taken for 6 weeks in Korean subjects with symptomatic OA of the knee.

Detailed Description

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Conditions

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Osteoarthritis Knee

Keywords

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knee, OA patients

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 10 mg tablet by mouth once daily for 6 weeks

Arm 2

Group Type ACTIVE_COMPARATOR

naproxen

Intervention Type DRUG

naproxen 500 mg capsule by mouth twice daily for 6 weeks

Interventions

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valdecoxib

valdecoxib 10 mg tablet by mouth once daily for 6 weeks

Intervention Type DRUG

naproxen

naproxen 500 mg capsule by mouth twice daily for 6 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Korean outpatients with symptomatic radiologic evidence of OA of the knee (diagnosed according to the modified American College Rheumatology criteria)
* Patient's Assessment of Arthritis Pain measurement of at least 40 mm on VAS
* Patients had not received any NSAIDs or analgesics within 2 days (within 4 days for subjects taking oxaprozin, piroxicam or full dose aspirin) prior to the Baseline Visit

Exclusion Criteria

* Diagnosis of inflammatory arthritis, gout, pseudogout, Paget's disease, or any chronic pain syndrome that, in the Investigator's opinion, would interfere with the assessment of the Index Knee
* Symptomatic anserine bursitis or acute joint trauma of the Index Knee
* Arthroscopy performed on the Index Knee within the past 12 months
* Complete loss of articular cartilage of the Index Knee
* Administration of oral, or intramuscular, intravenous, or soft tissue injections of corticosterosteroids within 4 weeks prior to screening visit
* Administration of intra-articular injection of corticosteroids or hyaluronic acid preparation in the Index Knee within 3 months or 6 months, respectively
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

Anyang, , South Korea

Site Status

Pfizer Investigational Site

Gwangju, , South Korea

Site Status

Pfizer Investigational Site

Incheon, , South Korea

Site Status

Pfizer Investigational Site

Pusan, , South Korea

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Countries

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South Korea

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3471045&StudyName=Double-blind%2C%20double%20dummy%2C%20randomized%20comparison%20study%20to%20evaluate%20the%20efficacy%20and%20safety%20of%20Valdecoxib%2010%20mg%20once%20daily%20and%20Napro

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Other Identifiers

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A3471045

Identifier Type: -

Identifier Source: org_study_id