Efficacy Study of "Go On" in Magnetic Resonance Imaging (MRI) Improvement in Osteoarthritis (OA) Knee

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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 MRI change after injection hyaluronic acid.

• The Hypothesis is 25 mg of sodium hyaluronate (2.5 ml) would preserve the joint space in patient with osteoarthritis of the knee compared to placebo .

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Khon Kaen University
• Treatments: Hyaluronic Acid

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.