Durolane Versus Methylprednisolone in Knee Osteoarthritis

Study Overview
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Brief Summary
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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.

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

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: Durolane is a device, methylprednisolone in a drug


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Durolane<br>intraarticular hyaluronic acid | Device: Durolane is a device, methylprednisolone in a drug<br>* single intraarticular injection<br>* Other names: Durolane and Depo-Medrol are the brand names;|
| Active Comparator: methylprednisolone<br>intraarticular injection | Device: Durolane is a device, methylprednisolone in a drug<br>* single intraarticular injection<br>* Other names: Durolane and Depo-Medrol are the brand names;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain level and responder rate |  | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC stiffness score | Will be assessed at each clinic visit | 26 weeks blinded phase + 26 weeks OLE | 
| WOMAC physical function | Will be assessed at each clinic visit | 26 weeks blinded phase + 26 weeks OLE | 
| Functional assessment | Will be assessed at each clinic visit | 26 weeks blinded phase + 26 weeks OLE | 
| Safety assessment (Adverse Events) | Will be assessed at each clinic visit using standard questions | 26 weeks blinded phase + 26 weeks OLE | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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double-blind, non-inferior, knee OA, comparative, randomized