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

This study has been completed.
Sponsor:
Collaborator:
Fidia Farmaceutici s.p.a.
Information provided by:
Med Pharma Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01319461
First received: March 18, 2011
Last updated: March 23, 2011
Last verified: March 2011
  Purpose

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 Intervention Phase
Osteoarthritis
Device: Hyalgan
Device: sterile normal saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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.

Resource links provided by NLM:


Further study details as provided by Med Pharma Co., Ltd.:

Enrollment: 200
Study Start Date: May 2001
Study Completion Date: June 2002
Primary Completion Date: June 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01319461

Locations
Taiwan
National taiwan university hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
Med Pharma Co., Ltd.
Fidia Farmaceutici s.p.a.
Investigators
Principal Investigator: Lin Ching Tsai, PhD National Taiwan University Hospital
  More Information

No publications provided by Med Pharma Co., Ltd.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eric Chang, Med Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT01319461     History of Changes
Other Study ID Numbers: UH-HYA-01-04
Study First Received: March 18, 2011
Last Updated: March 23, 2011
Health Authority: Taiwan : Food and Drug Administration

Keywords provided by Med Pharma Co., Ltd.:
Osteoarthritis
Hyalgan

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014