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)

Pfizer416 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

416

Conditions

Osteoarthritis, Knee

Interventions

valdecoxibDRUG

valdecoxib 5 mg tablet by mouth once daily in the morning for 6 weeks

valdecoxibDRUG

valdecoxib 10 mg tablet by mouth once daily in the morning for 6 weeks

valdecoxibDRUG

valdecoxib 20 mg tablet by mouth once daily in the morning for 6 weeks

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (22)

Pfizer Investigational Site

Funabashi, Chiba, Japan

Pfizer Investigational Site

Sakura, Chiba, Japan

Outcomes

Primary Outcomes

WOMAC (Western Ontario and McMaster Universities) OA Pain Index

Time frame: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6 (final visit)