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

NCT ID: NCT05592990

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-14

Study Completion Date

2026-01-27

Brief Summary

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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.

Detailed Description

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Conditions

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Achilles Tendinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NGI226

single peritendon injection

Group Type EXPERIMENTAL

NGI226

Intervention Type DRUG

NGI226 MP

Placebo

single peritendon injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo MP

Interventions

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NGI226

NGI226 MP

Intervention Type DRUG

Placebo

Placebo MP

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tucson Orthopedic Institute PC

Tucson, Arizona, United States

Site Status

Advanced Research LLC

Deerfield Beach, Florida, United States

Site Status

Houston Methodist Hospital

Houston, Texas, United States

Site Status

Novartis Investigative Site

Caluire-et-Cuire, , France

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Countries

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United States France Germany

Other Identifiers

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CNGI226A12201

Identifier Type: -

Identifier Source: org_study_id

2022-500863-10-00

Identifier Type: OTHER

Identifier Source: secondary_id