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

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	Phase III

MedlinePlus related topics:

Osteoarthritis

ChemIDplus related topics:

Sodium chloride Hyaluronate Sodium Hyaluronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Phase 3 Study GoON and MRI Improvement in OA Knee

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: 14 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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

Estimated Enrollment:	60
Study Start Date:	July 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
B: Placebo Comparator Normal saline	Drug: normal saline
A: Experimental 25 mg sodium hyaluronate	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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750724

Locations


Thailand
	Weerachai Kosuwon
	Khon Kaen, Thailand, 40001
	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:	Department of Orthopedics ( Faculty of Medicine )
Study ID Numbers:	OA hyaluronic acid1
First Received:	September 9, 2008
Last Updated:	September 9, 2008
ClinicalTrials.gov Identifier:	NCT00750724
Health Authority:	Thailand: Khon Kaen University Ethics Committee for Human Research

Keywords provided by Khon Kaen University:

Hyaluronic acid,

OA knee,

MRI

Study placed in the following topic categories:

Osteoarthritis, Knee

Musculoskeletal Diseases

Hyaluronic Acid

Osteoarthritis

Joint Diseases

Arthritis

Rheumatic Diseases

Additional relevant MeSH terms:

Immunologic Factors

Physiological Effects of Drugs

Adjuvants, Immunologic

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	Khon Kaen University
Information provided by:	Khon Kaen University
ClinicalTrials.gov Identifier:	NCT00750724