Clinical trial NCT01209364: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Knee Osteoarthritis
Keywords: comparative
randomized
double-blind
non-inferior
knee OA
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2010-09-27
Enrollment: 442
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pain level and responder rate
timeFrame: up to 12 weeks
Secondary outcomes:
measure: WOMAC stiffness score
timeFrame: 26 weeks blinded phase + 26 weeks OLE
measure: WOMAC physical function
timeFrame: 26 weeks blinded phase + 26 weeks OLE
measure: Functional assessment
timeFrame: 26 weeks blinded phase + 26 weeks OLE
measure: Safety assessment (Adverse Events)
timeFrame: 26 weeks blinded phase + 26 weeks OLE
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Bone & Joint Health Institute
state: Alberta
city: St John´s
country: Canada
facility: Nexus Clinical Research
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Orthopaedic & Sport Medicine Institute of Nova Scotia
state: Nova Scotia
city: Lunenburg
country: Canada
facility: Dr. Wilson
state: Nova Scotia
city: Halifax
country: Canada
facility: QEII Health Sciences Centre-New Halifax Infirmary
state: Ontario
city: Hamilton
country: Canada
facility: Charlton Medical Centre
state: Ontario
city: Hamilton
country: Canada
facility: MAC Research Inc.
state: Ontario
city: London
country: Canada
facility: Fowler Kennedy Sport Medicine Clinic
state: Ontario
city: Mississauga
country: Canada
facility: Credit Valley Rheumatology
state: Ontario
city: Newmarket
country: Canada
facility: The Arthritis Program Research Group
state: Ontario
city: Peterborough
country: Canada
facility: Dr. Dobson
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Sport C.A.R.E. Women's College Hospital
state: Ontario
city: Saint-Foy
country: Canada
facility: Centre de Rhumatologie St-Louis
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatoon Osteoporosis Centre
state: Saskatchewan
city: Göteborg
country: Sweden
facility: Läkargruppen Kristinelund
city: Johanneshov
country: Sweden
facility: Ortopediska huset
city: Malmö
country: Sweden
facility: Läkarhuset Ellenbogen
city: Stockholm
country: Sweden
facility: Ortopediska huset
city: London
country: United Kingdom
facility: Kings College Hospital - Department of Rheumatology
city: Newcastle
country: United Kingdom
facility: Newcastle University Clinical Research FacilityRoyal Victoria Infirmary
city: Oswestry
country: United Kingdom
facility: Robert Jones and Agnes Hunt Orthopaedic & District Hospital - Institute of Orthopaedics
city: Southampton
country: United Kingdom
facility: Southampton General Hospital - MRC Epidemiology Resource Center
Study officials:
References:
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.