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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-05-31

Study Completion Date

2002-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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sterile normal saline injection

Group Type PLACEBO_COMPARATOR

sterile normal saline

Intervention Type DEVICE

Patients will receive intraarticular injection of sterile normal saline once a week for 5 consecutive weeks.

Hyalgan injection

Group Type EXPERIMENTAL

Hyalgan

Intervention Type DEVICE

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

Interventions

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Hyalgan

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

Intervention Type DEVICE

sterile normal saline

Patients will receive intraarticular injection of sterile normal saline once a week for 5 consecutive weeks.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No