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COMPLETED
NCT05592990
PHASE2

A Study to Investigate the Safety, Tolerability and Preliminary Efficacy of NGI226 Microparticles in Patients With Achilles Tendinopathy

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

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

Interventions

DRUG

NGI226

NGI226 MP

DRUG

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