Status:
COMPLETED
A Dose-Ranging Study Of Valdecoxib 5 Mg, 10 Mg, And 20 Mg Once Daily Versus Placebo In Patients With Osteoarthritis Of The Knee (Japan)
Lead Sponsor:
Pfizer
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
To determine the therapeutic dose range of valdecoxib by comparing the efficacy of three dosing regimens (5 mg, 10 mg and 20 mg once daily) with placebo for relief of the signs and symptoms of osteoar...
Eligibility Criteria
Inclusion
- Patients diagnosed with symptomatic OA of the knee by the American College of Rheumatology (ACR) criteria and a Functional Capacity Classification (FCC) of I - III at Screening Visit and were walking
- At the Baseline visit, eligible patients were to have Patient's Assessment of Arthritis Pain VAS ≥ 40 mm and Patient's \& Physician's Global Assessment of Arthritis of "Poor" or "Very Poor"
Exclusion
- Patients unable to walk generally
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2004
Estimated Enrollment :
416 Patients enrolled
Trial Details
Trial ID
NCT00650624
Start Date
June 1 2003
End Date
January 1 2004
Last Update
December 11 2018
Active Locations (22)
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1
Pfizer Investigational Site
Funabashi, Chiba, Japan
2
Pfizer Investigational Site
Sakura, Chiba, Japan
3
Pfizer Investigational Site
Chikushi-gun, Fukuoka, Japan
4
Pfizer Investigational Site
Iizuka, Fukuoka, Japan