Back to resultsA Dose-Ranging Study Of Valdecoxib 5 Mg, 10 Mg, And 20 Mg Once Daily Versus Placebo In Patients With Osteoarthritis Of The Knee (Japan)
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
valdecoxib
valdecoxib
valdecoxib
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring knee osteoarthritis; Japan
Eligibility Criteria
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
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm 3
Arm 4
Arm Description
Outcomes
Primary Outcome Measures
WOMAC (Western Ontario and McMaster Universities) OA Pain Index
Secondary Outcome Measures
patients' and physicians' and 'categorical' global assessment of arthritis
WOMAC OA stiffness index
WOMAC OA physical function index
WOMAC OA composite index
WOMAC OA pain index, stiffness index, physical function index, and composite index
Incidence of and time to withdrawal due to lack of efficacy
patient's assessment of arthritis pain (Visual Analog Scale, VAS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00650624
Brief Title
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
A Dose-Ranging Study Of Valdecoxib 5 Mg, 10 Mg, And 20 Mg QD Versus Placebo In Patients With OA Of The Knee
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
knee osteoarthritis; Japan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
416 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Active Comparator
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Title
Arm 3
Arm Type
Active Comparator
Arm Title
Arm 4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
valdecoxib
Intervention Description
valdecoxib 5 mg tablet by mouth once daily in the morning for 6 weeks
Intervention Type
Drug
Intervention Name(s)
valdecoxib
Intervention Description
valdecoxib 10 mg tablet by mouth once daily in the morning for 6 weeks
Intervention Type
Drug
Intervention Name(s)
valdecoxib
Intervention Description
valdecoxib 20 mg tablet by mouth once daily in the morning for 6 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo tablet by mouth once daily in the morning for 6 weeks
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
patients' and physicians' and 'categorical' global assessment of arthritis
Time Frame
screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
Title
WOMAC OA stiffness index
Time Frame
screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
Title
WOMAC OA physical function index
Time Frame
screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
Title
WOMAC OA composite index
Time Frame
screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
Title
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
Title
Incidence of and time to withdrawal due to lack of efficacy
Time Frame
weeks 2, 4, and 6
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Funabashi
State/Province
Chiba
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sakura
State/Province
Chiba
Country
Japan
Facility Name
Pfizer Investigational Site
City
Chikushi-gun
State/Province
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Iizuka
State/Province
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kurume
State/Province
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yame
State/Province
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Chitose
State/Province
Hokkaido
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kamakura
State/Province
Kanagawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Isahaya
State/Province
Nagasaki
Country
Japan
Facility Name
Pfizer Investigational Site
City
Hirakata
State/Province
Osaka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kanzaki-gun
State/Province
Saga
Country
Japan
Facility Name
Pfizer Investigational Site
City
Karatsu
State/Province
Saga
Country
Japan
Facility Name
Pfizer Investigational Site
City
Ogi-gun
State/Province
Saga
Country
Japan
Facility Name
Pfizer Investigational Site
City
Itabashi-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Setagaya-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shinjuku-Ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Taito-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yoyogi Shibuya-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Saga
Country
Japan
Facility Name
Pfizer Investigational Site
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=VALAJP-8274-156&StudyName=A%20Dose-Ranging%20Study%20of%20Valdecoxib%205%20mg%2C%2010%20mg%2C%20and%2020%20mg%20Once%20Daily%20versus%20Placebo%20in%20Patients%20with%20Osteoarthritis%20of%20th
Description
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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)
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