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

NCT00750724 | Completed Phase 3 DMC

• 1 other identifier: Faculty of Medicine, Khon Kaen
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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 .

Conditions

Osteoarthritis

Keywords

Hyaluronic acid,; OA knee,; MRI

Outcome Measures

Primary Outcomes (1)

• MRI will be analysed with semiquantitative whole organ scoring method (WORMS) c

  6 months

Secondary Outcomes (1)

• WOMAC, VAS, side effects

  14 months

Study Arms (2)

B

PLACEBO COMPARATOR

2 ml of Normal saline intraarticular injection to the knee joint weekly for 5 weeks

Drug: normal saline,2 ml., intraarticular weekly for 5 weeks

A

EXPERIMENTAL

2 ml of 25 mg sodium hyaluronate intraarticular injection to the knee joint weekly for 5 weeks

Drug: 25 mg sodium hyaluronate "GO ON"

Interventions

25 mg sodium hyaluronate "GO ON" DRUG

25 mg sodium hyaluronate, 2 ml., intraarticular weekly for 5 weeks

A

normal saline,2 ml., intraarticular weekly for 5 weeks DRUG

B

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Weerachai Kosuwon

Khon Kaen, Changwat Khon Kaen, 40001, Thailand

Location

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Weerachai Kosuwon, Professor

  Faculty of Medicine, Khon Kaen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2008
• First Posted: September 10, 2008
• Study Start: July 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: October 1, 2009
• Last Updated: May 26, 2010

Record last verified: 2009-07

Locations

TH (1)