- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01209364
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
Intervention / Treatment
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
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Alberta
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Calgary, Alberta, Canada, T2P 3C5
- Alberta Bone & Joint Health Institute
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Newfoundland and Labrador
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St John´s, Newfoundland and Labrador, Canada, A1B 3E1
- Nexus Clinical Research
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 4M2
- Orthopaedic & Sport Medicine Institute of Nova Scotia
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Lunenburg, Nova Scotia, Canada, B0J2C0
- Dr. Wilson
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Ontario
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Halifax, Ontario, Canada, B3H 3A7
- QEII Health Sciences Centre-New Halifax Infirmary
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Hamilton, Ontario, Canada, L8N 1Y2
- Charlton medical Centre
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Hamilton, Ontario, Canada, L8N 2B6
- MAC Research Inc.
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London, Ontario, Canada, N6A 3K7
- Fowler Kennedy Sport Medicine Clinic
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Mississauga, Ontario, Canada, L5M 2V8
- Credit Valley Rheumatology
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Newmarket, Ontario, Canada, L3Y 3R7
- The Arthritis Program Research Group
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Peterborough, Ontario, Canada, K9J 6X2
- Dr. Dobson
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
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Toronto, Ontario, Canada, M5S 1B2
- Sport C.A.R.E. Women's College Hospital
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Quebec
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Saint-Foy, Quebec, Canada, G1W4R4
- Centre de Rhumatologie St-Louis
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7K 0H6
- Saskatoon Osteoporosis Centre
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Göteborg, Sweden, 411 37
- Läkargruppen Kristinelund
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Johanneshov, Sweden, 121 77
- Ortopediska huset
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Malmö, Sweden, 211 36
- Läkarhuset Ellenbogen
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Stockholm, Sweden, 11360
- Ortopediska huset
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London, United Kingdom, SE5 9RS
- Kings College Hospital - Department of Rheumatology
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Newcastle, United Kingdom, NE1 4LP
- Newcastle University Clinical Research FacilityRoyal Victoria Infirmary
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Oswestry, United Kingdom, SY10 7AG
- Robert Jones and Agnes Hunt Orthopaedic & District Hospital - Institute of Orthopaedics
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Southampton, United Kingdom, SO16 6YD
- Southampton General Hospital - MRC Epidemiology Resource Center
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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
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single intraarticular injection
Other Names:
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Active Comparator: methylprednisolone
intraarticular injection
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single intraarticular injection
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain level and responder rate
Time Frame: up to 12 weeks
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up to 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
WOMAC stiffness score
Time Frame: 26 weeks blinded phase + 26 weeks OLE
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Will be assessed at each clinic visit
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26 weeks blinded phase + 26 weeks OLE
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WOMAC physical function
Time Frame: 26 weeks blinded phase + 26 weeks OLE
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Will be assessed at each clinic visit
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26 weeks blinded phase + 26 weeks OLE
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Functional assessment
Time Frame: 26 weeks blinded phase + 26 weeks OLE
|
Will be assessed at each clinic visit
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26 weeks blinded phase + 26 weeks OLE
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Safety assessment (Adverse Events)
Time Frame: 26 weeks blinded phase + 26 weeks OLE
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Will be assessed at each clinic visit using standard questions
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26 weeks blinded phase + 26 weeks OLE
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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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Osteoarthritis
- Osteoarthritis, Knee
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Prednisolone
- Methylprednisolone Acetate
- Methylprednisolone
- Methylprednisolone Hemisuccinate
- Prednisolone acetate
- Prednisolone hemisuccinate
- Prednisolone phosphate
Other Study ID Numbers
- 35GA0608
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.
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