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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
45
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
Number of participants with AEs and SAEs
AEs and SAEs including ECG parameters, Lab Chemistry and Hematology parameters, urinalysis, local tolerability
Time frame: Up to Day 169 (End of Study)
Changes in tendon stiffness from baseline at week 12 assessed by ultrasound (US)-based shear wave elastography (SWE)
To assess the effects of a single peritendon injection of NGI226 MP versus placebo on restoration of biomechanical integrity of Achilles tendon
Time frame: Baseline, Week 12
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Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Hamburg, Germany
Novartis Investigative Site
Hamburg, Germany