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Durolane Versus Methylprednisolone in Knee Osteoarthritis

Sponsor
Galderma R&D (Industry)
Overall Status
Completed
CT.gov ID
NCT01209364
Collaborator
(none)
442
Enrollment
23
Locations
2
Arms
20.1
Duration (Months)
19.2
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Durolane is a device, methylprednisolone in a drug
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
442 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Double-Blind, Randomized, Parallel Group, Multicenter Study of Durolane Compared to Methylprednisolone in Subjects With Osteoarthritis of the Knee
Study Start Date :
Mar 1, 2007
Actual Primary Completion Date :
Jan 1, 2008
Actual Study Completion Date :
Nov 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: Durolane

intraarticular hyaluronic acid

Device: Durolane is a device, methylprednisolone in a drug
single intraarticular injection
Other Names:
  • Durolane and Depo-Medrol are the brand names

    		•
    Active Comparator: methylprednisolone

    intraarticular injection

    Device: Durolane is a device, methylprednisolone in a drug
    single intraarticular injection
    Other Names:
  • Durolane and Depo-Medrol are the brand names

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain level and responder rate [up to 12 weeks]

    Secondary Outcome Measures

    1. WOMAC stiffness score [26 weeks blinded phase + 26 weeks OLE]

      Will be assessed at each clinic visit

    2. WOMAC physical function [26 weeks blinded phase + 26 weeks OLE]

      Will be assessed at each clinic visit

    3. Functional assessment [26 weeks blinded phase + 26 weeks OLE]

      Will be assessed at each clinic visit

    4. Safety assessment (Adverse Events) [26 weeks blinded phase + 26 weeks OLE]

      Will be assessed at each clinic visit using standard questions

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Galderma R&D

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Galderma R&D
    ClinicalTrials.gov Identifier:
    NCT01209364
    Other Study ID Numbers:
    • 35GA0608
    First Posted:
    Sep 27, 2010
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Aug 1, 2007
    Keywords provided by Galderma R&D
    comparative
    randomized
    double-blind
    non-inferior
    knee OA
    Additional relevant MeSH terms:
    Osteoarthritis
    Osteoarthritis, Knee
    Methylprednisolone
    Methylprednisolone Acetate
    Methylprednisolone Hemisuccinate
    Prednisolone
    Prednisolone acetate
    Prednisolone hemisuccinate
    Prednisolone phosphate

    Study Results

    No Results Posted as of Aug 25, 2022