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)

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00650624

Collaborator

(none)

416

Enrollment

Locations

Arms

Duration (Months)

18.9

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee	Drug: valdecoxib Drug: valdecoxib Drug: valdecoxib Drug: placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

416 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Jun 1, 2003

Actual Study Completion Date :

Jan 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm 1	Drug: valdecoxib valdecoxib 5 mg tablet by mouth once daily in the morning for 6 weeks
Active Comparator: Arm 2	Drug: valdecoxib valdecoxib 10 mg tablet by mouth once daily in the morning for 6 weeks
Active Comparator: Arm 3	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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

patients' and physicians' and 'categorical' global assessment of arthritis [screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6]
WOMAC OA stiffness index [screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6]
WOMAC OA physical function index [screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6]
WOMAC OA composite index [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 [screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6]
Incidence of and time to withdrawal due to lack of efficacy [weeks 2, 4, and 6]
patient's assessment of arthritis pain (Visual Analog Scale, VAS) [screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country
1	Pfizer Investigational Site	Funabashi	Chiba	Japan
2	Pfizer Investigational Site	Sakura	Chiba	Japan
3	Pfizer Investigational Site	Chikushi-gun	Fukuoka	Japan
4	Pfizer Investigational Site	Iizuka	Fukuoka	Japan
5	Pfizer Investigational Site	Kurume	Fukuoka	Japan
6	Pfizer Investigational Site	Yame	Fukuoka	Japan
7	Pfizer Investigational Site	Chitose	Hokkaido	Japan
8	Pfizer Investigational Site	Sapporo	Hokkaido	Japan
9	Pfizer Investigational Site	Kamakura	Kanagawa	Japan
10	Pfizer Investigational Site	Yokohama	Kanagawa	Japan
11	Pfizer Investigational Site	Isahaya	Nagasaki	Japan
12	Pfizer Investigational Site	Hirakata	Osaka	Japan
13	Pfizer Investigational Site	Kanzaki-gun	Saga	Japan
14	Pfizer Investigational Site	Karatsu	Saga	Japan
15	Pfizer Investigational Site	Ogi-gun	Saga	Japan
16	Pfizer Investigational Site	Itabashi-ku	Tokyo	Japan
17	Pfizer Investigational Site	Setagaya-ku	Tokyo	Japan
18	Pfizer Investigational Site	Shinjuku-Ku	Tokyo	Japan
19	Pfizer Investigational Site	Taito-ku	Tokyo	Japan
20	Pfizer Investigational Site	Yoyogi Shibuya-ku	Tokyo	Japan
21	Pfizer Investigational Site	Saga		Japan
22	Pfizer Investigational Site	Tokyo		Japan