Status:
COMPLETED
Efficacy Study of "Go On" in Magnetic Resonance Imaging (MRI) Improvement in Osteoarthritis (OA) Knee
Lead Sponsor:
Khon Kaen University
Conditions:
Osteoarthritis
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
Brief Summary
OA knee is a common degenerative diseases of the joint. * There are many methods to treat this condition. * Hyaluronic acid is one of the recomended treatment of OA knee. * There is no any study on M...
Detailed Description
This will be the phase III randomized, double-blind, placebo-controlled trial of 52 weeks duration designed to evaluate the efficacy of sodium hyaluronate to placebo (saline), in adult with OA of the ...
Eligibility Criteria
Inclusion
- Subjects who are capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Ambulatory non pregnant females and males 40-\<80 years of age.
- Subjects who withdraw pain medication or nutritional supplements for symptom relief for OA hand for a total of at least 30 days before screening visit 0.
- Pain at or below 40 mm on a 100 mm VAS in the index knee joints.
- A documented diagnosis of OA of the knee joint, or meeting American College of Rheumatology (ACR) clinical criteria for classification of idiopathic (primary) OA for at least 6 months prior to screening.
- Subject has been documented radiographic evidence of OA of the knees from the screening Visit radiograph of grade 2 or 3 according to Kellgren and Lawrence Radiographic Grading.
- Subject has no any contraindication for MRI
- Subject is able to understand and complete pain/function, global arthritis evaluation, and health outcome assessment.
Exclusion
- Subjects with history of hypersensitivity to hyaluronate.
- Subjects with skin lesion at the knee joint.
- A history of knee surgery within 6 months prior to screening V0.
- Significant prior injury to the knee joint within 12 months prior to screening V0.
- Disease of the spine or other lower extremity joints of sufficient degree to affect the knee joint.
- Treatment with other drugs potentially affecting bone or cartilage metabolism as described below:
- chronic systematic corticosteroids
- Diacerin or glucosamine treatment within the last 12 months.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00750724
Start Date
July 1 2008
End Date
October 1 2009
Last Update
May 26 2010
Active Locations (1)
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1
Weerachai Kosuwon
Khon Kaen, Changwat Khon Kaen, Thailand, 40001