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

NCT05592990

CompletedPhase 2

Sponsor: Novartis Pharmaceuticals

Conditions: Achilles Tendinopathy

Interventions: NGI226, Placebo

Countries: United States, France, Germany

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 overview

Sex: ALL

Age: 30 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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, Arizona, United States
  • Deerfield Beach, Florida, United States
  • Houston, Texas, United States
  • Caluire-et-Cuire, France
  • Berlin, Germany
  • Hamburg, Germany
  • Hamburg, Germany