Clinical trial NCT01430559: Effect Of Meloxicam Versus Placebo In Mainland Chinese Patients With Osteoarthritis Of The Knee
Official title: A DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PARALLEL GROUP STUDY OF THE EFFECT OF MELOXICAM IN MAINLAND CHINESE SUBJECTS WITH OSTEOARTHRITIS (OA) OF THE KNEE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of the Knee
Keywords: Validation of the WOMAC in Chinese subjects with osteoarthritis of the knee
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-09-08
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is to validate the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) tool in mainland Chinese patients with osteoarthritis of the knee . This study will also evaluate the effects of Mobic versus placebo on reducing the symptoms of osteoarthritis in this population.

Detailed description: To validate culturally the WOMAC tool in mainland China and observe the different response of meloxicam and placebo in a patient population with osteoarthritis of the knee

Eligibility criteria: Inclusion Criteria:

Subjects are required to meet the following criteria to be eligible for Randomization into this study:

* Male or female Chinese subjects, 18-75 years of age;
* Subjects must have a diagnosis of OA of the index knee based on American College of Rheumatology criteria with X ray confirmation (a Kellgren Lawrence x ray grade of greater than or equal to 2) (Kellgren J. \& Lawrence J, 1957)
* Subjects must have have an NRS and a WOMAC pain sub scale score of 4 at Screening and at Baseline based on four daily diary entries

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

* History of other disease that may involve the index (painful) knee including inflammatory joint diseases or have had recent surgical intervention on the knee.
* Diagnosed as having or has been treated for esophageal, gastric, pyloric channel, or duodenal ulceration within 30 days prior to receiving the first dose of study medication. History of or active gastrointestinal disease (eg, inflammatory bowel disease), a chronic or acute renal or hepatic disorder, or a significant coagulation defect.
* Signs and symptoms of clinically significant cardiac disease

Primary outcomes:
measure: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Screening 1 by Using a Paper Worksheet and a Personalized Electronic LogPad System (E-diary)
timeFrame: Screening 1 (Visit 1: Days -21 to -14)
measure: WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Screening 2 by Using E-diary
timeFrame: Screening 2 (Visit 2: Days -14 to -10)
measure: WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Baseline by Using E-diary
timeFrame: Baseline (Day 1)
measure: WOMAC Total and the 3 Subscales Scores (Pain, Stiffness and Physical Function) at Week 12 by Using E-diary
timeFrame: Visit 8 (Week 12)
measure: Change From Baseline in WOMAC Pain Subscale Scores at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline in WOMAC Subscale and Average Scores at Weeks 2, 4, 8 and 12
timeFrame: Baseline, Weeks 2, 4, 8 and 12
measure: Change From Baseline in WOMAC Pain Subscale Items at Weeks 2, 4, 8 and 12
timeFrame: Baseline, Weeks 2, 4, 8 and 12
measure: Percentage of Participants With Cumulative Reduction From Baseline in WOMAC Pain Subscale at Week 12
timeFrame: Baseline and Week 12
measure: Percentage of Participants With at Least 30% and 50% Reduction From Baseline in the WOMAC Pain Subscale at Weeks 2, 4, 8, and 12
timeFrame: Baseline, Weeks 2, 4, 8 and 12
measure: Change From Baseline in Patient Global Assessment of Osteoarthritis (PGAO) at Weeks 2, 4, 8 and 12
timeFrame: Baseline, Weeks 2, 4, 8 and 12
measure: Percentage of Participants With >=2 Points Improvement in PGAO From Baseline at Weeks 2, 4, 8, and 12
timeFrame: Baseline, Weeks 2, 4, 8 and 12
measure: Change From Baseline in Short-Form 36 Health Survey (SF-36) Domain Scores and Component Scores at Week 12
timeFrame: Baseline and Week 12
measure: Percentage of Participants With Change From Baseline in EuroQoL-5 Domains (EQ-5D) Level at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Weekly Average Pain Score in the Index Knee Using 11-point Numeric Rating Scale (NRS) at Weeks 2, 4, 8 and 12
timeFrame: Baseline, Weeks 2, 4, 8 and 12
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Province Hospital
state: Anhui
city: Guangzhou
country: China
facility: The Third Affiliated Hospital Of Sun Yat-sen University
state: Guangdong
city: Shantou City
country: China
facility: The First Affiliated Hospital of Shantou Medical Collage
state: Guangdong
city: Harbin
country: China
facility: Rheumatology Department, The first Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Shenyang
country: China
facility: Rheumatology Department, The First Hospital of China Medical University
state: Liaoning
city: Jinan
country: China
facility: QiLu Hospital of Shandong University
state: Shandong
city: Liaocheng
country: China
facility: Liaocheng People's Hospital/Orthopaedics
state: Shandong
city: Qingdao
country: China
facility: Department of Immunology and Rheumatology, Qingdao Municipal Hospital
state: Shandong
city: Qingdao
country: China
facility: Department of Immunology and Rheumatology,Qingdao Municipal Hospital
state: Shandong
city: Xi'an
country: China
facility: Xijing Hospital, The Fourth Military Medical University
state: Shanxi
city: Chengdu
country: China
facility: Department of Orthopedics, West China Hospital of Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: Department of Rheumatology and Immunology,West China Hospital of Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: Department of Rheumatology and Immunology, Sichuan Provincial People's Hospital
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital, Rheumatology
state: Sichuan
city: Beijing
country: China
facility: China-Japan Friendship Hospital/Rheumatology Department
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Li Zhanguo
city: Beijing
country: China
facility: Rheumatology and Immunology Department, Xuanwu Hospital Capital Medical University
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Orthopaedics
city: Shanghai
country: China
facility: Renji Hospital Shanghai Jiao Tong University School of Medicine
city: Shanghai
country: China
facility: Rheumatology and Immunology Department, Shanghai Changzheng Hospital
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University, Rheumatology Department
city: Tianjin
country: China
facility: Department of Infectious Diseases & Immunology, Tianjin Medical University General Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: