Status:
COMPLETED
Safety, Tolerability, and Pharmacokinetics of Single Dose TenoMiR as a Treatment for Tennis Elbow
Lead Sponsor:
Causeway Therapeutics
Conditions:
Tennis Elbow
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This study is testing a drug called TenoMiR that is being developed for the treatment of tennis elbow (lateral epicondylitis). The study drug is a new compound that works by improving the quality of t...
Detailed Description
TenoMiR a chemically synthesised mimic of microRNA-29a (miR29a) which has improved stability, activity and cellular uptake while being non-immunogenic, has been created to restore miR29a levels back t...
Eligibility Criteria
Inclusion
- Subject has a clinical diagnosis of lateral epicondylitis.
- Aside from lateral epicondylitis, the subject is otherwise healthy as determined by a responsible physician, based on medical history, physical examinations, concomitant medication, vital signs, 12-lead ECGs and clinical laboratory evaluations. Laboratory values may be re-tested once at the discretion of the Investigator.
- 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 chair sign).
- Subject's symptoms have persisted for at least 6 weeks to 6 months, despite conservative treatment that includes 1 or combinations of:
- Physical therapy
- Splinting
- NSAIDs
Exclusion
- Subjects with any of the following will be excluded from study participation:
- Subject has undergone previous corticosteroid injection therapy to the affected elbow 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 affected elbow.
- 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 treatment of lateral epicondylitis.
Key Trial Info
Start Date :
August 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04670289
Start Date
August 14 2020
End Date
August 18 2021
Last Update
September 17 2021
Active Locations (1)
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1
MAC Clinical Research
Manchester, United Kingdom