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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00650624
Recruitment Status : Completed
First Posted : April 2, 2008
Last Update Posted : December 11, 2018
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE March 31, 2008
First Posted Date  ICMJE April 2, 2008
Last Update Posted Date December 11, 2018
Study Start Date  ICMJE June 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2008)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2008)
  • patients' and physicians' and 'categorical' global assessment of arthritis [ Time Frame: 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 ]
  • WOMAC OA physical function index [ Time Frame: 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 ]
  • 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 ]
  • Incidence of and time to withdrawal due to lack of efficacy [ Time Frame: 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE A Dose-Ranging Study Of Valdecoxib 5 Mg, 10 Mg, And 20 Mg QD Versus Placebo In Patients With OA Of The Knee
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE
  • 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
  • Drug: placebo
    placebo tablet by mouth once daily in the morning for 6 weeks
Study Arms  ICMJE
  • Active Comparator: Arm 1
    Intervention: Drug: valdecoxib
  • Active Comparator: Arm 2
    Intervention: Drug: valdecoxib
  • Active Comparator: Arm 3
    Intervention: Drug: valdecoxib
  • Placebo Comparator: Arm 4
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 31, 2008)
416
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00650624
Other Study ID Numbers  ICMJE VALAJP-8274-156
A3471090
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP