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

NCT01319461 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2011-03-25

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Hyalgan

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

DEVICE

sterile normal saline

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

Sponsors & Collaborators

  • Fidia Farmaceutici s.p.a.

    collaborator INDUSTRY

  • Med Pharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Lin Ching Tsai, PhD · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-05-31
Primary Completion
2002-06-30
Completion
2002-06-30

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01319461 on ClinicalTrials.gov