Phase
Condition
Tennis Elbow
Treatment
TenoMiR
0.9% Sodium Chloride Injection
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects must meet all of the following inclusion criteria.
Subject has a clinical diagnosis of lateral epicondylitis.
Aside from lateral epicondylitis, the subject is otherwise healthy as determined bya responsible physician, based on medical history, physical examinations,concomitant medication, vital signs, 12-lead ECGs and clinical laboratoryevaluations. Laboratory values may be retested once at the discretion of theInvestigator.
Subject's symptoms can be reproduced with resisted supination or wrist dorsiflexion (as confirmed by tenderness at lateral epicondyle and positive pick up back of chairsign).
Subject's symptoms have persisted for at least 6 weeks to 9 months, despiteconservative treatment that includes 1 or combinations of:
Physical therapy
Splinting
NSAIDs
Exclusion
Exclusion Criteria:
Subjects with any of the following will be excluded from study participation:
Subject has undergone previous corticosteroid injection therapy to the affectedelbow in less than 6 months prior to enrolment.
Subjects unwilling or unable to discontinue use of pain medication (opiate or NSAID)from at least 1 week prior to Investigational Medicinal Product (IMP)administration.
Subject has received previous Platelet-Rich Plasma (PRP) injection to the affectedelbow.
Subject uses or has recent use of medications known to affect the skeleton (e.g.,glucocorticoid usage >5 mg/day, fluoroquinolone antibiotics).
Subject has undergone surgical intervention to the affected elbow for the treatmentof lateral epicondylitis.
Study Design
Study Description
Connect with a study center
Panthera Biopartners
Enfield Town, EN3 4GS
United KingdomSite Not Available
Glasgow Clinical Research Facility
Glasgow,
United KingdomSite Not Available
Panthera Biopartners
Glasgow, G51 4TY
United KingdomSite Not Available
Panthera Biopartners
Preston, PR2 9QB
United KingdomSite Not Available
Panthera Biopartners
Rochdale, OL11 4AU
United KingdomSite Not Available
Panthera Biopartners
Sheffield, S2 5FX
United KingdomSite Not Available
Stanford Medicine
Redwood City, California 94063
United StatesSite Not Available
Hospital for Special Surgery
New York, New York 10021
United StatesSite Not Available
NYU Langone Health
New York, New York 10022
United StatesSite Not Available
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