Durolane Versus Methylprednisolone in Knee Osteoarthritis

August 24, 2022 updated by: Galderma R&D

Double-Blind, Randomized, Parallel Group, Multicenter Study of Durolane Compared to Methylprednisolone in Subjects With Osteoarthritis of the Knee

The primary objective is to determine whether Durolane is non-inferior to methylprednisolone, as assessed by level of pain, when each are given as single intra-articular injections for the relief of pain, in the treatment of symptomatic osteoarthritis of the knee at 12 weeks.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

442

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alberta
      • Calgary, Alberta, Canada, T2P 3C5
        • Alberta Bone & Joint Health Institute
    • Newfoundland and Labrador
      • St John´s, Newfoundland and Labrador, Canada, A1B 3E1
        • Nexus Clinical Research
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 4M2
        • Orthopaedic & Sport Medicine Institute of Nova Scotia
      • Lunenburg, Nova Scotia, Canada, B0J2C0
        • Dr. Wilson
    • Ontario
      • Halifax, Ontario, Canada, B3H 3A7
        • QEII Health Sciences Centre-New Halifax Infirmary
      • Hamilton, Ontario, Canada, L8N 1Y2
        • Charlton medical Centre
      • Hamilton, Ontario, Canada, L8N 2B6
        • MAC Research Inc.
      • London, Ontario, Canada, N6A 3K7
        • Fowler Kennedy Sport Medicine Clinic
      • Mississauga, Ontario, Canada, L5M 2V8
        • Credit Valley Rheumatology
      • Newmarket, Ontario, Canada, L3Y 3R7
        • The Arthritis Program Research Group
      • Peterborough, Ontario, Canada, K9J 6X2
        • Dr. Dobson
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada, M5S 1B2
        • Sport C.A.R.E. Women's College Hospital
    • Quebec
      • Saint-Foy, Quebec, Canada, G1W4R4
        • Centre de Rhumatologie St-Louis
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 0H6
        • Saskatoon Osteoporosis Centre
      • Göteborg, Sweden, 411 37
        • Läkargruppen Kristinelund
      • Johanneshov, Sweden, 121 77
        • Ortopediska huset
      • Malmö, Sweden, 211 36
        • Läkarhuset Ellenbogen
      • Stockholm, Sweden, 11360
        • Ortopediska huset
      • London, United Kingdom, SE5 9RS
        • Kings College Hospital - Department of Rheumatology
      • Newcastle, United Kingdom, NE1 4LP
        • Newcastle University Clinical Research FacilityRoyal Victoria Infirmary
      • Oswestry, United Kingdom, SY10 7AG
        • Robert Jones and Agnes Hunt Orthopaedic & District Hospital - Institute of Orthopaedics
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital - MRC Epidemiology Resource Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

33 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject (female or male) 35-80 years of age
  • Unilateral knee pain
  • Radiographic evidence of OA
  • WOMAC pain score of 7-17
  • Subject normally active
  • Subject has attempted but not responded adequately to previous non-pharmacological therapy(ies);
  • Subject cooperative and able to communicate effectively with the investigators;
  • Body mass index ≤ 40 kg/m2;
  • Signed informed consent obtained.

Exclusion Criteria:

  • Knee effusion
  • Contralateral knee OA
  • Clinically significant joint pain from joints other than the knee
  • Previous intra-articular steroid injection into the study knee within the last 3 months;
  • Previous intra-articular HA injection into the study knee within the last 9 months;
  • Previous allergic type reaction to a HA product, a steroid, or lidocaine/related anesthetics;
  • Treatment with analgesics other than paracetamol (acetaminophen) (including topical agents for the knee) within 5 half lives of the drug prior to the baseline visit;
  • Use of systemic glucocorticosteroids (excluding inhaled steroids) within the last 3 months;
  • Treatment with glucosamine/chondroitin sulfate initiated within the past 3 months
  • Change in physical therapy for the knee within the last three months
  • Arthroscopy or other surgical procedure in the study knee within the past 12 months;
  • Any planned arthroscopy or other surgical procedure during the study period;
  • Previous history or presence of active septic arthritis
  • Active skin disease or infection in the area of the injection site;
  • Systemic active inflammatory condition or infection
  • Bleeding diathesis or use of anticoagulants
  • Current uncontrolled diabetes mellitus;
  • Any medical condition that in the opinion of the investigator makes the subject unsuitable for inclusion
  • Pregnant or breastfeeding woman or woman of childbearing potential not practicing adequate contraception;
  • Involvement in other clinical trials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Durolane
intraarticular hyaluronic acid
single intraarticular injection
Other Names:
  • Durolane and Depo-Medrol are the brand names
Active Comparator: methylprednisolone
intraarticular injection
single intraarticular injection
Other Names:
  • Durolane and Depo-Medrol are the brand names

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain level and responder rate
Time Frame: up to 12 weeks
up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOMAC stiffness score
Time Frame: 26 weeks blinded phase + 26 weeks OLE
Will be assessed at each clinic visit
26 weeks blinded phase + 26 weeks OLE
WOMAC physical function
Time Frame: 26 weeks blinded phase + 26 weeks OLE
Will be assessed at each clinic visit
26 weeks blinded phase + 26 weeks OLE
Functional assessment
Time Frame: 26 weeks blinded phase + 26 weeks OLE
Will be assessed at each clinic visit
26 weeks blinded phase + 26 weeks OLE
Safety assessment (Adverse Events)
Time Frame: 26 weeks blinded phase + 26 weeks OLE
Will be assessed at each clinic visit using standard questions
26 weeks blinded phase + 26 weeks OLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

September 20, 2010

First Submitted That Met QC Criteria

September 24, 2010

First Posted (Estimate)

September 27, 2010

Study Record Updates

Last Update Posted (Actual)

August 25, 2022

Last Update Submitted That Met QC Criteria

August 24, 2022

Last Verified

August 1, 2007

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Knee Osteoarthritis

Clinical Trials on Durolane is a device, methylprednisolone in a drug

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