Effect Of Meloxicam Versus Placebo In Mainland Chinese Patients With Osteoarthritis Of The Knee
NCT ID: NCT01430559
Last Updated: 2020-12-31
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
408 participants
INTERVENTIONAL
2011-10-24
2013-03-27
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Meloxicam
Meloxicam
7.5mg x2 once a day for 12 weeks
Placebo
2 Placebo capsules once a day for 12 weeks
Placebo
Study subjects will be randomized to two treatment groups: one with Meloxicam 7.5 mgx2 once a day and another one with placebo. The duration of the interventional treatment is 12 weeks.
Interventions
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Meloxicam
7.5mg x2 once a day for 12 weeks
Placebo
Study subjects will be randomized to two treatment groups: one with Meloxicam 7.5 mgx2 once a day and another one with placebo. The duration of the interventional treatment is 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Anhui Province Hospital
Hefei, Anhui, China
The Third Affiliated Hospital Of Sun Yat-sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Shantou Medical Collage
Shantou, Guangdong, China
Rheumatology Department, The first Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Rheumatology Department, The First Hospital of China Medical University
Shenyang, Liaoning, China
QiLu Hospital of Shandong University
Jinan, Shandong, China
Liaocheng People's Hospital/Orthopaedics
Liaocheng, Shandong, China
Department of Immunology and Rheumatology, Qingdao Municipal Hospital
Qingdao, Shandong, China
Department of Immunology and Rheumatology,Qingdao Municipal Hospital
Qingdao, Shandong, China
Xijing Hospital, The Fourth Military Medical University
Xi’an, Shanxi, China
Department of Orthopedics, West China Hospital of Sichuan University
Chengdu, Sichuan, China
Department of Rheumatology and Immunology,West China Hospital of Sichuan University
Chengdu, Sichuan, China
Department of Rheumatology and Immunology, Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Sichuan Provincial People's Hospital, Rheumatology
Chengdu, Sichuan, China
China-Japan Friendship Hospital/Rheumatology Department
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
Li Zhanguo
Beijing, , China
Rheumatology and Immunology Department, Xuanwu Hospital Capital Medical University
Beijing, , China
Peking Union Medical College Hospital, Orthopaedics
Beijing, , China
Renji Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Rheumatology and Immunology Department, Shanghai Changzheng Hospital
Shanghai, , China
Zhongshan Hospital Fudan University, Rheumatology Department
Shanghai, , China
Department of Infectious Diseases & Immunology, Tianjin Medical University General Hospital
Tianjin, , China
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A9001449
Identifier Type: -
Identifier Source: org_study_id