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

This study has been completed.
Sponsor:
Information provided by:
Khon Kaen University
ClinicalTrials.gov Identifier:
NCT00750724
First received: September 9, 2008
Last updated: May 25, 2010
Last verified: July 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • WOMAC, VAS, side effects [ Time Frame: 14 months ] [ Designated as safety issue: Yes ]

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
Other Name: 25 mg sodium hyaluronate "GO ON"

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

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Faculty of Medicine, Department of Orthopedics
ClinicalTrials.gov Identifier: NCT00750724     History of Changes
Other Study ID Numbers: Faculty of Medicine, Khon Kaen
Study First Received: September 9, 2008
Last Updated: May 25, 2010
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research

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
Pharmacologic Actions
Viscosupplements
Protective Agents

ClinicalTrials.gov processed this record on September 16, 2014