Trials / Completed
CompletedNCT05592990
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 30 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NGI226 | NGI226 MP |
| DRUG | Placebo | Placebo MP |
Timeline
- Start date
- 2023-06-14
- Primary completion
- 2026-02-03
- Completion
- 2026-02-03
- First posted
- 2022-10-25
- Last updated
- 2026-03-30
Locations
7 sites across 3 countries: United States, France, Germany
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05592990. Inclusion in this directory is not an endorsement.