Status:
COMPLETED
Effect Of Meloxicam Versus Placebo In Mainland Chinese Patients With Osteoarthritis Of The Knee
Lead Sponsor:
Pfizer
Conditions:
Osteoarthritis of the Knee
Eligibility:
All Genders
18-75 years
Phase:
NA
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 t...
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
- 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
- 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
Key Trial Info
Start Date :
October 24 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2013
Estimated Enrollment :
408 Patients enrolled
Trial Details
Trial ID
NCT01430559
Start Date
October 24 2011
End Date
March 27 2013
Last Update
December 31 2020
Active Locations (25)
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1
Anhui Province Hospital
Hefei, Anhui, China, 230001
2
The Third Affiliated Hospital Of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
3
The First Affiliated Hospital of Shantou Medical Collage
Shantou, Guangdong, China, 515041
4
Rheumatology Department, The first Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150001