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Durolane Versus Methylprednisolone in Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Durolane is a device, methylprednisolone in a drug
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring comparative, randomized, double-blind, non-inferior, knee OA

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alberta Bone & Joint Health Institute
  • Nexus Clinical Research
  • Orthopaedic & Sport Medicine Institute of Nova Scotia
  • Dr. Wilson
  • QEII Health Sciences Centre-New Halifax Infirmary
  • Charlton Medical Centre
  • MAC Research Inc.
  • Fowler Kennedy Sport Medicine Clinic
  • Credit Valley Rheumatology
  • The Arthritis Program Research Group
  • Dr. Dobson
  • Sunnybrook Health Sciences Centre
  • Sport C.A.R.E. Women's College Hospital
  • Centre de Rhumatologie St-Louis
  • Saskatoon Osteoporosis Centre
  • Läkargruppen Kristinelund
  • Ortopediska huset
  • Läkarhuset Ellenbogen
  • Ortopediska huset
  • Kings College Hospital - Department of Rheumatology
  • Newcastle University Clinical Research FacilityRoyal Victoria Infirmary
  • Robert Jones and Agnes Hunt Orthopaedic & District Hospital - Institute of Orthopaedics
  • Southampton General Hospital - MRC Epidemiology Resource Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Durolane

methylprednisolone

Arm Description

intraarticular hyaluronic acid

intraarticular injection

Outcomes

Primary Outcome Measures

Pain level and responder rate

Secondary Outcome Measures

WOMAC stiffness score
Will be assessed at each clinic visit
WOMAC physical function
Will be assessed at each clinic visit
Functional assessment
Will be assessed at each clinic visit
Safety assessment (Adverse Events)
Will be assessed at each clinic visit using standard questions

Full Information

First Posted
September 20, 2010
Last Updated
August 24, 2022
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT01209364
Brief Title
Durolane Versus Methylprednisolone in Knee Osteoarthritis
Official Title
Double-Blind, Randomized, Parallel Group, Multicenter Study of Durolane Compared to Methylprednisolone in Subjects With Osteoarthritis of the Knee
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
comparative, randomized, double-blind, non-inferior, knee OA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
442 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Durolane
Arm Type
Experimental
Arm Description
intraarticular hyaluronic acid
Arm Title
methylprednisolone
Arm Type
Active Comparator
Arm Description
intraarticular injection
Intervention Type
Device
Intervention Name(s)
Durolane is a device, methylprednisolone in a drug
Other Intervention Name(s)
Durolane and Depo-Medrol are the brand names
Intervention Description
single intraarticular injection
Primary Outcome Measure Information:
Title
Pain level and responder rate
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
WOMAC stiffness score
Description
Will be assessed at each clinic visit
Time Frame
26 weeks blinded phase + 26 weeks OLE
Title
WOMAC physical function
Description
Will be assessed at each clinic visit
Time Frame
26 weeks blinded phase + 26 weeks OLE
Title
Functional assessment
Description
Will be assessed at each clinic visit
Time Frame
26 weeks blinded phase + 26 weeks OLE
Title
Safety assessment (Adverse Events)
Description
Will be assessed at each clinic visit using standard questions
Time Frame
26 weeks blinded phase + 26 weeks OLE

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Alberta Bone & Joint Health Institute
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2P 3C5
Country
Canada
Facility Name
Nexus Clinical Research
City
St John´s
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3E1
Country
Canada
Facility Name
Orthopaedic & Sport Medicine Institute of Nova Scotia
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 4M2
Country
Canada
Facility Name
Dr. Wilson
City
Lunenburg
State/Province
Nova Scotia
ZIP/Postal Code
B0J2C0
Country
Canada
Facility Name
QEII Health Sciences Centre-New Halifax Infirmary
City
Halifax
State/Province
Ontario
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Charlton Medical Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1Y2
Country
Canada
Facility Name
MAC Research Inc.
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 2B6
Country
Canada
Facility Name
Fowler Kennedy Sport Medicine Clinic
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3K7
Country
Canada
Facility Name
Credit Valley Rheumatology
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 2V8
Country
Canada
Facility Name
The Arthritis Program Research Group
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 3R7
Country
Canada
Facility Name
Dr. Dobson
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 6X2
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Sport C.A.R.E. Women's College Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 1B2
Country
Canada
Facility Name
Centre de Rhumatologie St-Louis
City
Saint-Foy
State/Province
Quebec
ZIP/Postal Code
G1W4R4
Country
Canada
Facility Name
Saskatoon Osteoporosis Centre
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 0H6
Country
Canada
Facility Name
Läkargruppen Kristinelund
City
Göteborg
ZIP/Postal Code
411 37
Country
Sweden
Facility Name
Ortopediska huset
City
Johanneshov
ZIP/Postal Code
121 77
Country
Sweden
Facility Name
Läkarhuset Ellenbogen
City
Malmö
ZIP/Postal Code
211 36
Country
Sweden
Facility Name
Ortopediska huset
City
Stockholm
ZIP/Postal Code
11360
Country
Sweden
Facility Name
Kings College Hospital - Department of Rheumatology
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Newcastle University Clinical Research FacilityRoyal Victoria Infirmary
City
Newcastle
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Robert Jones and Agnes Hunt Orthopaedic & District Hospital - Institute of Orthopaedics
City
Oswestry
ZIP/Postal Code
SY10 7AG
Country
United Kingdom
Facility Name
Southampton General Hospital - MRC Epidemiology Resource Center
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24185114
Citation
Leighton R, Akermark C, Therrien R, Richardson JB, Andersson M, Todman MG, Arden NK; DUROLANE Study Group. NASHA hyaluronic acid vs. methylprednisolone for knee osteoarthritis: a prospective, multi-centre, randomized, non-inferiority trial. Osteoarthritis Cartilage. 2014 Jan;22(1):17-25. doi: 10.1016/j.joca.2013.10.009. Epub 2013 Nov 1.
Results Reference
derived

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Durolane Versus Methylprednisolone in Knee Osteoarthritis

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