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Completed

NCT Number: NCT00650624

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)

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Funabashi, Chiba, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

valdecoxib

Drug

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

Placebo

Drug

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. patients' and physicians' and 'categorical' global assessment of arthritis

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

  2. WOMAC OA stiffness index

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

  3. WOMAC OA physical function index

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

  4. WOMAC OA composite index

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

  5. WOMAC OA pain index, stiffness index, physical function index, and composite index

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

  6. Incidence of and time to withdrawal due to lack of efficacy

    Time frame: weeks 2, 4, and 6

  7. patient's assessment of arthritis pain (Visual Analog Scale, VAS)

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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2004
First posted
Apr 2, 2008
Registry last updated
Dec 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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