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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00750724
First Posted: September 10, 2008
Last Update Posted: May 26, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Khon Kaen University
  Purpose

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 .

Condition Intervention Phase
Osteoarthritis Drug: 25 mg sodium hyaluronate "GO ON" Drug: normal saline,2 ml., intraarticular weekly for 5 weeks Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3 Study GoON and MRI Improvement in OA Knee

Resource links provided by NLM:


Further study details as provided by Khon Kaen University:

Primary Outcome Measures:
  • MRI will be analysed with semiquantitative whole organ scoring method (WORMS) c [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • WOMAC, VAS, side effects [ Time Frame: 14 months ]

Enrollment: 60
Study Start Date: July 2008
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: B
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
Experimental: A
2 ml of 25 mg sodium hyaluronate intraarticular injection to the knee joint weekly for 5 weeks
Drug: 25 mg sodium hyaluronate "GO ON"
25 mg sodium hyaluronate, 2 ml., intraarticular weekly for 5 weeks

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 knee joints. Randomization will be stratified by Kellgren-Lawrence(KL) grade (garde2 or 3), by subjects X-ray. A total of 60 subjects are planed for enrollment in this study. The study will be conducted over approximately 52 weeks.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00750724


Locations
Thailand
Weerachai Kosuwon
Khon Kaen, Thailand, 40001
Sponsors and Collaborators
Khon Kaen University
Investigators
Principal Investigator: Weerachai Kosuwon, Professor Faculty of Medicine, Khon Kaen University
  More Information

Responsible Party: Faculty of Medicine, Department of Orthopedics
ClinicalTrials.gov Identifier: NCT00750724     History of Changes
Other Study ID Numbers: Faculty of Medicine, Khon Kaen
First Submitted: September 9, 2008
First Posted: September 10, 2008
Last Update Posted: May 26, 2010
Last Verified: July 2009

Keywords provided by Khon Kaen University:
Hyaluronic acid,
OA knee,
MRI

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents