Knee Osteoarthritis
Conditions
Keywords
comparative, randomized, double-blind, non-inferior, knee OA
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.
Interventions
DEVICEDurolane is a device, methylprednisolone in a drug
single intraarticular injection
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain level and responder rate | up to 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| WOMAC stiffness score | 26 weeks blinded phase + 26 weeks OLE | Will be assessed at each clinic visit |
| WOMAC physical function | 26 weeks blinded phase + 26 weeks OLE | Will be assessed at each clinic visit |
| Functional assessment | 26 weeks blinded phase + 26 weeks OLE | Will be assessed at each clinic visit |
| Safety assessment (Adverse Events) | 26 weeks blinded phase + 26 weeks OLE | Will be assessed at each clinic visit using standard questions |
Countries
Canada, Sweden, United Kingdom
Outcome results
None listed