Durolane Versus Methylprednisolone in Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Double-Blind, Randomized, Parallel Group, Multicenter Study of Durolane Compared to Methylprednisolone in Subjects With Osteoarthritis of the Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01209364
• Other study ID #: 35GA0608
• Status: Completed
• Phase: Phase 3
• Start date: March 2007
• Est. completion date: November 2008

Study information

• Verified date: August 2007
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 442
• Est. completion date: November 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Durolane is a device, methylprednisolone in a drug
single intraarticular injection

Locations

Country	Name	City	State
Canada	Alberta Bone & Joint Health Institute	Calgary	Alberta
Canada	Orthopaedic & Sport Medicine Institute of Nova Scotia	Halifax	Nova Scotia
Canada	QEII Health Sciences Centre-New Halifax Infirmary	Halifax	Ontario
Canada	Charlton Medical Centre	Hamilton	Ontario
Canada	MAC Research Inc.	Hamilton	Ontario
Canada	Fowler Kennedy Sport Medicine Clinic	London	Ontario
Canada	Dr. Wilson	Lunenburg	Nova Scotia
Canada	Credit Valley Rheumatology	Mississauga	Ontario
Canada	The Arthritis Program Research Group	Newmarket	Ontario
Canada	Dr. Dobson	Peterborough	Ontario
Canada	Centre de Rhumatologie St-Louis	Saint-Foy	Quebec
Canada	Saskatoon Osteoporosis Centre	Saskatoon	Saskatchewan
Canada	Nexus Clinical Research	St John´s	Newfoundland and Labrador
Canada	Sport C.A.R.E. Women's College Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Sweden	Läkargruppen Kristinelund	Göteborg
Sweden	Ortopediska huset	Johanneshov
Sweden	Läkarhuset Ellenbogen	Malmö
Sweden	Ortopediska huset	Stockholm
United Kingdom	Kings College Hospital - Department of Rheumatology	London
United Kingdom	Newcastle University Clinical Research FacilityRoyal Victoria Infirmary	Newcastle
United Kingdom	Robert Jones and Agnes Hunt Orthopaedic & District Hospital - Institute of Orthopaedics	Oswestry
United Kingdom	Southampton General Hospital - MRC Epidemiology Resource Center	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

Canada,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain level and responder rate		up to 12 weeks
Secondary	WOMAC stiffness score	Will be assessed at each clinic visit	26 weeks blinded phase + 26 weeks OLE
Secondary	WOMAC physical function	Will be assessed at each clinic visit	26 weeks blinded phase + 26 weeks OLE
Secondary	Functional assessment	Will be assessed at each clinic visit	26 weeks blinded phase + 26 weeks OLE
Secondary	Safety assessment (Adverse Events)	Will be assessed at each clinic visit using standard questions	26 weeks blinded phase + 26 weeks OLE