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)

A Dose-Ranging Study Of Valdecoxib 5 Mg, 10 Mg, And 20 Mg QD Versus Placebo In Patients With OA Of The Knee

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00650624

Enrollment

416

Registered

2008-04-02

Start date

2003-06-30

Completion date

2004-01-31

Last updated

2018-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Keywords

knee osteoarthritis; Japan

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

Interventions

DRUGvaldecoxib

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

DRUGplacebo

placebo tablet by mouth once daily in the morning for 6 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
WOMAC (Western Ontario and McMaster Universities) OA Pain Index	screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6 (final visit)

Secondary

Measure	Time frame
WOMAC OA stiffness index	screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
WOMAC OA physical function index	screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
WOMAC OA composite index	screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
patients' and physicians' and 'categorical' global assessment of arthritis	screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
Incidence of and time to withdrawal due to lack of efficacy	weeks 2, 4, and 6
patient's assessment of arthritis pain (Visual Analog Scale, VAS)	screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
WOMAC OA pain index, stiffness index, physical function index, and composite index	screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026