Durolane Versus Methylprednisolone in Knee Osteoarthritis
Information source: Q-Med AB
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Knee Osteoarthritis
Intervention: Durolane is a device, methylprednisolone in a drug (Device)
Phase: Phase 3
Status: Completed
Sponsored by: Q-Med AB
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.
Clinical Details
Official title: Double-Blind, Randomized, Parallel Group, Multicenter Study of Durolane Compared to Methylprednisolone in Subjects With Osteoarthritis of the Knee
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Pain level and responder rate
Secondary outcome: WOMAC stiffness scoreWOMAC physical function Functional assessment Safety assessment (Adverse Events)
Eligibility
Minimum age: 35 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Läkargruppen Kristinelund, Göteborg 411 37, Sweden
Ortopediska huset, Johanneshov 121 77, Sweden
Läkarhuset Ellenbogen, Malmö 211 36, Sweden
Ortopediska huset, Stockholm 11360, Sweden
Kings College Hospital - Department of Rheumatology, London SE5 9RS, United Kingdom
Newcastle University Clinical Research FacilityRoyal Victoria Infirmary, Newcastle NE1 4LP, United Kingdom
Robert Jones and Agnes Hunt Orthopaedic & District Hospital - Institute of Orthopaedics, Oswestry SY10 7AG, United Kingdom
Southampton General Hospital - MRC Epidemiology Resource Center, Southampton SO16 6YD, United Kingdom
Alberta Bone & Joint Health Institute, Calgary, Alberta T2P 3C5, Canada
Nexus Clinical Research, St John´s, Newfoundland and Labrador A1B 3E1, Canada
Orthopaedic & Sport Medicine Institute of Nova Scotia, Halifax, Nova Scotia B3H 4M2, Canada
Dr. Wilson, Lunenburg, Nova Scotia B0J2C0, Canada
QEII Health Sciences Centre-New Halifax Infirmary, Halifax, Ontario B3H 3A7, Canada
Charlton Medical Centre, Hamilton, Ontario L8N 1Y2, Canada
MAC Research Inc., Hamilton, Ontario L8N 2B6, Canada
Fowler Kennedy Sport Medicine Clinic, London, Ontario N6A 3K7, Canada
Credit Valley Rheumatology, Mississauga, Ontario L5M 2V8, Canada
The Arthritis Program Research Group, Newmarket, Ontario L3Y 3R7, Canada
Dr. Dobson, Peterborough, Ontario K9J 6X2, Canada
Sport C.A.R.E. Women's College Hospital, Toronto, Ontario M5S 1B2, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario M4N 3M5, Canada
Centre de Rhumatologie St-Louis, Saint-Foy, Quebec G1W4R4, Canada
Saskatoon Osteoporosis Centre, Saskatoon, Saskatchewan S7K 0H6, Canada
Additional Information
Starting date: March 2007
Last updated: November 6, 2012
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