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A Study to Investigate the Safety, Tolerability and Preliminary Efficacy of NGI226 Microparticles in Patients With Achilles Tendinopathy | Clinical Trials | Clareo Health

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

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

NCT05592990•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.

Eligibility

Age

30 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Written informed consent must be obtained prior to all study specific screening procedures, as close to the start of the screening period as possible.
•Presence of clinically (local Achilles tendon pain on tendon-loading activities, pain on palpation at the level 2-6 cm proximal to the calcaneal insertion) and ultrasound (local tendon thickening with hypoechogenicities and irregular fibre orientation) or MRI diagnosed mid-portion Achilles tendinopathy with symptoms present ≥8 weeks but \<12 months at screening.
•The Achilles tendinopathy must have been refractory to at least 6 weeks of conservative treatment (physiotherapy, NSAIDS, RICE), but participants do not need to be in physiotherapy at the time of study entry.

Exclusion Criteria

•Medical condition that would affect safety of peritendon injection (e.g., peripheral vascular disease, use of anticoagulant medication)
•History of recurrent, acute, symptomatic infections, including outbreaks of oral or genital herpes (\> 2 symptomatic infections or \>2 courses of anti-infective treatments required in the last 6 months; active systemic infection during last 2 weeks; known active infections (e.g. chronic or active Hepatis B or C, HIV) - simple cold excluded
•History or evidence of clinically significant cardiac or cardiovascular disease
•History of deep vein thrombosis, pulmonary embolism or evidence of primary or secondary hypercoagulable states
•History of surgical intervention for the treatment of tendinopathy, history of ankle surgery, ankle arthritis, traumatic, inflammation or deformity of ankle
•History of full-thickness tear or complete rupture of the Achilles tendon

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

Key Dates

Start Date

June 14, 2023

Primary Completion Date

February 3, 2026

Completion Date

February 3, 2026

Last Updated

February 20, 2026

Enrollment

ACTUAL participants

Conditions

Achilles Tendinopathy

Interventions

NGI226

DRUG

Placebo

DRUG

Evaluation of Collagen-based Medical Device Treatment Combined With Physiotherapy in Subjects With Achilles Tendinopathy.

NCT05464498

TendinopathyInsertional Achilles Tendinopathy+2 more

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NOT_YET_RECRUITINGNA

Extracorporeal Shockwave Therapy and Platelet-Rich Plasma for Midportion Achilles Tendinopathy

NCT07483320

Achilles Injuries TendonAchilles Tendinopathy (AT)+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Evaluation of Collagen-based Medical Device Treatment Combined With Physiotherapy in Subjects With Achilles Tendinopathy.

Extracorporeal Shockwave Therapy and Platelet-Rich Plasma for Midportion Achilles Tendinopathy

Ozone Injection vs ESWT for Chronic Achilles Tendinopathy

Eccentric Exercises Versus Heel Insole Lift for Achilles Tendinopathy in Football Players

Evaluation of the Course and Effectiveness of Conservative Therapy in Patients With Achilles Tendinopathy

Pilot Investigation to Evaluate Effectiveness of Shockwave Therapy, Photobiomodulation and Physical Therapy in the Management of Non-insertional Achilles Tendinopathy