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)

Pfizer

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis, Knee

Treatments: Drug: valdecoxib; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00650624

VALAJP-8274-156

A3471090

Details and patient eligibility

About

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 osteoarthritis of the knee. To assess safety and tolerability of multiple doses of valdecoxib in patients with osteoarthritis of the knee.

Enrollment: 416 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• Patients unable to walk generally

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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416 participants in 4 patient groups, including a placebo group

Arm 1

Active Comparator group

Treatment:

Drug: valdecoxib

Drug: valdecoxib

Drug: valdecoxib

Arm 2

Active Comparator group

Treatment:

Drug: valdecoxib

Drug: valdecoxib

Drug: valdecoxib

Arm 3

Active Comparator group

Treatment:

Drug: valdecoxib

Drug: valdecoxib

Drug: valdecoxib

Arm 4

Placebo Comparator group

Treatment:

Drug: placebo