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)

NCT00650624

Last updated date
Study Location
Pfizer Investigational Site
Funabashi, Chiba, , Japan
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Knee Osteoarthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Patients unable to walk generally

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Advanced Information
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 CenterPfizer
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