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)

Osteoarthritis, Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00650624
• Other study ID #: VALAJP-8274-156
• Secondary ID: A3471090
• Status: Completed
• Phase: Phase 2
• Start date: June 2003
• Est. completion date: January 2004

Study information

• Verified date: December 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 416
• Est. completion date: January 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• valdecoxib
valdecoxib 5 mg tablet by mouth once daily in the morning for 6 weeks
• valdecoxib
valdecoxib 10 mg tablet by mouth once daily in the morning for 6 weeks
• valdecoxib
valdecoxib 20 mg tablet by mouth once daily in the morning for 6 weeks
• placebo
placebo tablet by mouth once daily in the morning for 6 weeks

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Chikushi-gun	Fukuoka
Japan	Pfizer Investigational Site	Chitose	Hokkaido
Japan	Pfizer Investigational Site	Funabashi	Chiba
Japan	Pfizer Investigational Site	Hirakata	Osaka
Japan	Pfizer Investigational Site	Iizuka	Fukuoka
Japan	Pfizer Investigational Site	Isahaya	Nagasaki
Japan	Pfizer Investigational Site	Itabashi-ku	Tokyo
Japan	Pfizer Investigational Site	Kamakura	Kanagawa
Japan	Pfizer Investigational Site	Kanzaki-gun	Saga
Japan	Pfizer Investigational Site	Karatsu	Saga
Japan	Pfizer Investigational Site	Kurume	Fukuoka
Japan	Pfizer Investigational Site	Ogi-gun	Saga
Japan	Pfizer Investigational Site	Saga
Japan	Pfizer Investigational Site	Sakura	Chiba
Japan	Pfizer Investigational Site	Sapporo	Hokkaido
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	Tokyo
Japan	Pfizer Investigational Site	Yame	Fukuoka
Japan	Pfizer Investigational Site	Yokohama	Kanagawa
Japan	Pfizer Investigational Site	Yoyogi Shibuya-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC (Western Ontario and McMaster Universities) OA Pain Index		screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6 (final visit)
Secondary	patients' and physicians' and 'categorical' global assessment of arthritis		screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
Secondary	WOMAC OA stiffness index		screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
Secondary	WOMAC OA physical function index		screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
Secondary	WOMAC OA composite index		screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
Secondary	WOMAC OA pain index, stiffness index, physical function index, and composite index		screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
Secondary	Incidence of and time to withdrawal due to lack of efficacy		weeks 2, 4, and 6
Secondary	patient's assessment of arthritis pain (Visual Analog Scale, VAS)		screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6

External Links

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