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Viscosupplementation
Durolane SJ for Osteoarthritis
Phase 4
Waitlist Available
Led By Alistair Younger, MD
Research Sponsored by Bioventus LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial
Summary
26 week open label study of treatment with Durolane for OA pain of the ankle
Eligible Conditions
- Osteoarthritis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Durolane SJExperimental Treatment1 Intervention
Durolane SJ intra-articular injection; device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durolane SJ
2013
N/A
~40
Find a Location
Who is running the clinical trial?
Bioventus LLCLead Sponsor
16 Previous Clinical Trials
15,194 Total Patients Enrolled
10 Trials studying Osteoarthritis
1,681 Patients Enrolled for Osteoarthritis
Alistair Younger, MDPrincipal InvestigatorSt. Pauls Hospital
1 Previous Clinical Trials
250 Total Patients Enrolled
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