Effect Of Meloxicam Versus Placebo In Mainland Chinese Patients With Osteoarthritis Of The Knee
NCT01430559
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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
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
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Descriptive Information | |||||
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Brief Title ICMJE | Effect Of Meloxicam Versus Placebo In Mainland Chinese Patients With Osteoarthritis Of The Knee | ||||
Official Title ICMJE | A DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PARALLEL GROUP STUDY OF THE EFFECT OF MELOXICAM IN MAINLAND CHINESE SUBJECTS WITH OSTEOARTHRITIS (OA) OF THE KNEE | ||||
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 | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Other | ||||
Condition ICMJE | Osteoarthritis of the Knee | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE | 408 | ||||
Original Estimated Enrollment ICMJE | 334 | ||||
Actual Study Completion Date ICMJE | March 27, 2013 | ||||
Actual Primary Completion Date | March 27, 2013 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria: Subjects are required to meet the following criteria to be eligible for Randomization into this study:
Exclusion Criteria: Subjects presenting with any of the following will not be included in the study:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT01430559 | ||||
Other Study ID Numbers ICMJE | A9001449 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||
Verification Date | December 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |