Knee OsteoarthritisPhase 3NCT01209364
Durolane Versus Methylprednisolone in Knee Osteoarthritis
A Phase 3 study testing Durolane is a device, methylprednisolone in a drug in people with Knee Osteoarthritis, run by Galderma R&D at 23 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Durolane is a device, methylprednisolone in a drug
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 442 participants
- Where
- 23 sitesin 3 countries
- Study dates
- Mar 2007to Nov 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- Subject cooperative and able to communicate effectively with the investigators;
- Body mass index ≤ 40 kg/m2;
- Signed informed consent obtained.
Who cannot join
- 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;
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- 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
Trial locations and contacts
23 sites in 3 countries.
23 sites in 3 countries
Canada15 sites
Alberta Bone & Joint Health Institute
Calgary, Alberta, T2P 3C5
Orthopaedic & Sport Medicine Institute of Nova Scotia
Halifax, Nova Scotia, B3H 4M2
QEII Health Sciences Centre-New Halifax Infirmary
Halifax, Ontario, B3H 3A7
Charlton Medical Centre
Hamilton, Ontario, L8N 1Y2
MAC Research Inc.
Hamilton, Ontario, L8N 2B6
Fowler Kennedy Sport Medicine Clinic
London, Ontario, N6A 3K7
Dr. Wilson
Lunenburg, Nova Scotia, B0J2C0
Credit Valley Rheumatology
Mississauga, Ontario, L5M 2V8
The Arthritis Program Research Group
Newmarket, Ontario, L3Y 3R7
Dr. Dobson
Peterborough, Ontario, K9J 6X2
Centre de Rhumatologie St-Louis
Saint-Foy, Quebec, G1W4R4
Saskatoon Osteoporosis Centre
Saskatoon, Saskatchewan, S7K 0H6
Nexus Clinical Research
St. John's, Newfoundland and Labrador, A1B 3E1
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Sport C.A.R.E. Women's College Hospital
Toronto, Ontario, M5S 1B2
Sweden4 sites
Läkargruppen Kristinelund
Gothenburg, 411 37
Ortopediska huset
Johanneshov, 121 77
Läkarhuset Ellenbogen
Malmö, 211 36
Ortopediska huset
Stockholm, 11360
United Kingdom4 sites
Kings College Hospital - Department of Rheumatology
London, SE5 9RS
Newcastle University Clinical Research FacilityRoyal Victoria Infirmary
Newcastle, NE1 4LP
Robert Jones and Agnes Hunt Orthopaedic & District Hospital - Institute of Orthopaedics
Oswestry, SY10 7AG
Southampton General Hospital - MRC Epidemiology Resource Center
Southampton, SO16 6YD
About this study
Official title: 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Durolane is a device, methylprednisolone in a drug
- Keywords
- comparative, randomized, double-blind, non-inferior, knee OA
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Durolane is a device, methylprednisolone in a drugDevice
Also called Durolane and Depo-Medrol are the brand names
single intraarticular injection
| Study group | Role | What they receive |
|---|---|---|
| Durolane | Experimental | intraarticular hyaluronic acid Receives: Device: Durolane is a device, methylprednisolone in a drug |
| methylprednisolone | Active comparator | intraarticular injection Receives: Device: Durolane is a device, methylprednisolone in a drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level and responder rate
Measured: up to 12 weeks
Secondary outcomes (4)
WOMAC stiffness score
Will be assessed at each clinic visit
Measured: 26 weeks blinded phase + 26 weeks OLE
WOMAC physical function
Will be assessed at each clinic visit
Measured: 26 weeks blinded phase + 26 weeks OLE
Functional assessment
Will be assessed at each clinic visit
Measured: 26 weeks blinded phase + 26 weeks OLE
Safety assessment (Adverse Events)
Will be assessed at each clinic visit using standard questions
Measured: 26 weeks blinded phase + 26 weeks OLE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2010 (estimated)
- Study startMar 2007
- Primary completionJan 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01209364
- Sponsor's protocol ID
- 35GA0608
- Status last verified
- Aug 2007
- First submitted
- 20 Sep 2010
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24185114
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Randomized, Parallel Group, Multicenter Study of Durolane Compared to Methylprednisolone in Subjects With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT01209364
- Acronym / sponsor ID
- 35GA0608
- Conditions
- Knee Osteoarthritis
- Keywords
- comparative, randomized, double-blind, non-inferior, knee OA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 27 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Durolane | Experimental | Device: Durolane is a device, methylprednisolone in a drugintraarticular hyaluronic acid |
| methylprednisolone | Active comparator | Device: Durolane is a device, methylprednisolone in a drugintraarticular injection |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Durolane is a device, methylprednisolone in a drugAlso: Durolane and Depo-Medrol are the brand namessingle intraarticular injection | Device | Durolane, methylprednisolone |
Primary outcome
Pain level and responder rate
Time frame: up to 12 weeks
4 secondary outcomes
WOMAC stiffness score
Time frame: 26 weeks blinded phase + 26 weeks OLE
WOMAC physical function
Time frame: 26 weeks blinded phase + 26 weeks OLE
Functional assessment
Time frame: 26 weeks blinded phase + 26 weeks OLE
Safety assessment (Adverse Events)
Time frame: 26 weeks blinded phase + 26 weeks OLE
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Derived from this study: PubMed 24185114Leighton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Durolane is a device, methylprednisolone in a drug in people with Knee Osteoarthritis, run by Galderma R&D at 23 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Canada, Sweden, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level and responder rate (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01209364, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.