Clinical trial NCT00650624: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis, Knee
Keywords: knee osteoarthritis; Japan
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-02
Enrollment: 416
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: WOMAC (Western Ontario and McMaster Universities) OA Pain Index
timeFrame: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6 (final visit)
Secondary outcomes:
measure: patients' and physicians' and 'categorical' global assessment of arthritis
timeFrame: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
measure: WOMAC OA stiffness index
timeFrame: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
measure: WOMAC OA physical function index
timeFrame: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
measure: WOMAC OA composite index
timeFrame: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
measure: WOMAC OA pain index, stiffness index, physical function index, and composite index
timeFrame: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
measure: Incidence of and time to withdrawal due to lack of efficacy
timeFrame: weeks 2, 4, and 6
measure: patient's assessment of arthritis pain (Visual Analog Scale, VAS)
timeFrame: screening (Day -14), baseline (week 0), and at weeks 2, 4, and 6
Other outcomes:
Locations:
city: Funabashi
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Sakura
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Chikushi-gun
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Iizuka
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Kurume
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Yame
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Chitose
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Kamakura
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Isahaya
country: Japan
facility: Pfizer Investigational Site
state: Nagasaki
city: Hirakata
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Kanzaki-gun
country: Japan
facility: Pfizer Investigational Site
state: Saga
city: Karatsu
country: Japan
facility: Pfizer Investigational Site
state: Saga
city: Ogi-gun
country: Japan
facility: Pfizer Investigational Site
state: Saga
city: Itabashi-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Taito-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Yoyogi Shibuya-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Saga
country: Japan
facility: Pfizer Investigational Site
city: Tokyo
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: