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Efficacy and Safety of Intraarticular Injections of Hyalgan in the Treatment of Osteoarthritis of the Knee

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. Identifier: NCT01319461
Recruitment Status : Completed
First Posted : March 21, 2011
Last Update Posted : March 25, 2011
Fidia Farmaceutici s.p.a.
Information provided by:
Med Pharma Co., Ltd.

Brief Summary:
Evaluate the efficacy and safety of Hyalgan, at a dose of 20mg/2ml administered as 5 intraarticular injections at weekly intervals, for the sustained relief of pain and amelioration of joint dysfunction in patients of OA of the knee.

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: Hyalgan Device: sterile normal saline Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Intraarticular Injections of Hyalgan in the Treatment of Osteoarthritis of the Knee: a Randomized, Masked Observed, Double Blind, Placebo Controlled, Multicenter Clinical Trial.
Study Start Date : May 2001
Actual Primary Completion Date : June 2002
Actual Study Completion Date : June 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Placebo Comparator: sterile normal saline injection Device: sterile normal saline
Patients will receive intraarticular injection of sterile normal saline once a week for 5 consecutive weeks.

Experimental: Hyalgan injection Device: Hyalgan
Patients will receive intraarticular injection of 20mg /2ml /syringe Hyalgan® once a week for 5 consecutive weeks.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 1.Male or female patients whose specific ages are > 50 years old, in general health. 2.Must be ambulatory (assistive devices allowed) 3.Patient was diagnosed as OA of knee joint by American College of Rheumatology (ACR) criteria ; [ ie,knee pain, and any one of the following:age>50 years,crepitus, or morning stiffness<30 minutes in duration ] 4.Radiographic confirmation of OA with Kellgren-Lawrence Ⅱ-Ⅲ score (mild to moderate)at the target joint (anterior-posterior views) with predominance in the tibia-femoral compartment 5.VAS score ≧40 mm for 50 foot of walking pain.

Exclusion Criteria:

  • 1.Patients with severe degeneration of knee joint with marked joint narrowing, marked varus or valgus deformity of the knee greater than 12 o. 2.Patients with hepatic or renal failure, or other chronic severe diseases that can interfere with the outcome. 3.A known history of psychiatric diseases, significant neurological diseases, allergy or sensitivity to hyaluronic acid or avian protein. 4.Patients receive steroid intraarticular injection, anti-inflammatory agents less than two weeks. 5.Patients with joint disorders: inflammatory joint disease, specific arthropathy (chondrocalcinosis, joint effusion >30ml), severe axis deviations or instabilities, joint or skin infections, joint prostheses of the lower limbs, symptomatic hip. 6.Significant alcohol, drug or medication abuse as judged by the investigator. 7.Pregnancy determined by clinical evaluation or urine testing for nursing women and/or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm or Norplant). 8.Patients who have taken any other "investigational" drug within one month prior to the screening visit.

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 identifier (NCT number): NCT01319461

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National taiwan university hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
Med Pharma Co., Ltd.
Fidia Farmaceutici s.p.a.
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Principal Investigator: Lin Ching Tsai, PhD National Taiwan University Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Eric Chang, Med Pharma Co., Ltd. Identifier: NCT01319461    
Other Study ID Numbers: UH-HYA-01-04
First Posted: March 21, 2011    Key Record Dates
Last Update Posted: March 25, 2011
Last Verified: March 2011
Keywords provided by Med Pharma Co., Ltd.:
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Protective Agents