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)

December 7, 2018 updated by: Pfizer

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

416

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Saga, Japan
        • Pfizer Investigational Site
      • Tokyo, Japan
        • Pfizer Investigational Site
    • Chiba
      • Funabashi, Chiba, Japan
        • Pfizer Investigational Site
      • Sakura, Chiba, Japan
        • Pfizer Investigational Site
    • Fukuoka
      • Chikushi-gun, Fukuoka, Japan
        • Pfizer Investigational Site
      • Iizuka, Fukuoka, Japan
        • Pfizer Investigational Site
      • Kurume, Fukuoka, Japan
        • Pfizer Investigational Site
      • Yame, Fukuoka, Japan
        • Pfizer Investigational Site
    • Hokkaido
      • Chitose, Hokkaido, Japan
        • Pfizer Investigational Site
      • Sapporo, Hokkaido, Japan
        • Pfizer Investigational Site
    • Kanagawa
      • Kamakura, Kanagawa, Japan
        • Pfizer Investigational Site
      • Yokohama, Kanagawa, Japan
        • Pfizer Investigational Site
    • Nagasaki
      • Isahaya, Nagasaki, Japan
        • Pfizer Investigational Site
    • Osaka
      • Hirakata, Osaka, Japan
        • Pfizer Investigational Site
    • Saga
      • Kanzaki-gun, Saga, Japan
        • Pfizer Investigational Site
      • Karatsu, Saga, Japan
        • Pfizer Investigational Site
      • Ogi-gun, Saga, Japan
        • Pfizer Investigational Site
    • Tokyo
      • Itabashi-ku, Tokyo, Japan
        • Pfizer Investigational Site
      • Setagaya-ku, Tokyo, Japan
        • Pfizer Investigational Site
      • Shinjuku-Ku, Tokyo, Japan
        • Pfizer Investigational Site
      • Taito-ku, Tokyo, Japan
        • Pfizer Investigational Site
      • Yoyogi Shibuya-ku, Tokyo, Japan
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Arm 2
Drug: valdecoxib
valdecoxib 5 mg tablet by mouth once daily in the morning for 6 weeks
Drug: valdecoxib
valdecoxib 10 mg tablet by mouth once daily in the morning for 6 weeks
Drug: valdecoxib
valdecoxib 20 mg tablet by mouth once daily in the morning for 6 weeks
ACTIVE_COMPARATOR: Arm 1
Drug: valdecoxib
valdecoxib 5 mg tablet by mouth once daily in the morning for 6 weeks
Drug: valdecoxib
valdecoxib 10 mg tablet by mouth once daily in the morning for 6 weeks
Drug: valdecoxib
valdecoxib 20 mg tablet by mouth once daily in the morning for 6 weeks
PLACEBO_COMPARATOR: Arm 4
Drug: placebo
placebo tablet by mouth once daily in the morning for 6 weeks
ACTIVE_COMPARATOR: Arm 3
Drug: valdecoxib
valdecoxib 5 mg tablet by mouth once daily in the morning for 6 weeks
Drug: valdecoxib
valdecoxib 10 mg tablet by mouth once daily in the morning for 6 weeks
Drug: valdecoxib
valdecoxib 20 mg tablet by mouth once daily in the morning for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6 (final visit)

Secondary Outcome Measures

Outcome Measure
Time Frame
patients' and physicians' and 'categorical' global assessment of arthritis
Time Frame: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
WOMAC OA stiffness index
Time Frame: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
WOMAC OA physical function index
Time Frame: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
WOMAC OA composite index
Time Frame: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
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
Time Frame: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
Incidence of and time to withdrawal due to lack of efficacy
Time Frame: weeks 2, 4, and 6
weeks 2, 4, and 6
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
screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Study Completion (ACTUAL)

January 1, 2004

Study Registration Dates

First Submitted

March 31, 2008

First Submitted That Met QC Criteria

March 31, 2008

First Posted (ESTIMATE)

April 2, 2008

Study Record Updates

Last Update Posted (ACTUAL)

December 11, 2018

Last Update Submitted That Met QC Criteria

December 7, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VALAJP-8274-156
  • A3471090

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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