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A Study to Investigate the Safety, Tolerability and Preliminary Efficacy of NGI226 Microparticles in Patients With Achilles Tendinopathy
Sponsor: Novartis Pharmaceuticals
Summary
The purpose of this study is to measure local and systemic safety and tolerability as well as improvement of Achilles tendon mechanical properties after a single peritendon injection of NGI226 MP in comparison to placebo MP in patients with mid-portion Achilles tendinopathy.
Official title: A Two Part, Randomized, Participant and Investigator-blinded, 2-arm, Parallel-design, Placebo-controlled Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of NGI226 Microparticles on Tendon Regeneration in Patients With Achilles Tendinopathy
Key Details
Gender
All
Age Range
30 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2023-06-14
Completion Date
2026-02-03
Last Updated
2026-06-23
Healthy Volunteers
No
Conditions
Interventions
NGI226
NGI226 MP
Placebo
Placebo MP
Locations (7)
Tucson Orthopedic Institute PC
Tucson, Arizona, United States
Advanced Research LLC
Deerfield Beach, Florida, United States
Houston Methodist Hospital
Houston, Texas, United States
Novartis Investigative Site
Caluire-et-Cuire, France
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Hamburg, Germany
Novartis Investigative Site
Hamburg, Germany