A Study to Investigate the Safety, Tolerability and Preliminary Efficacy of NGI226 Microparticles in Patients With Achilles Tendinopathy
Completed · Phase 2 · Has a placebo group
Conditions studied: Achilles Tendinopathy
In brief
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.
Key facts
- Study ID
- NCT05592990
- Run by
- Novartis Pharmaceuticals
- People needed
- 45
- Starts
- 2023-06-14
- Expected to finish
- 2026-02-03
- Last updated by the study team
- 2026-06-23
Who can join
Age: 30 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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