Overview

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.