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

Launched by NOVARTIS PHARMACEUTICALS · Oct 20, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called NGI226 microparticles for patients suffering from Achilles tendinopathy, which is pain in the Achilles tendon often caused by overuse. The main goal of the study is to check how safe and tolerable this treatment is and whether it can improve the strength and function of the Achilles tendon after a single injection near the tendon. Researchers will compare the results of patients receiving the NGI226 treatment to those receiving a placebo, which is an inactive substance.

To participate in the trial, individuals must have been experiencing tendon pain for at least 8 weeks but less than 12 months, and their condition should not have improved with standard treatments like physical therapy. Eligible participants must be able to give written consent and should not have certain medical conditions that could make the injection unsafe. The trial is currently recruiting patients of all genders aged 18 to 65. If you join the study, you can expect to receive either the treatment or a placebo and be monitored closely for any side effects or improvements in your condition.

Gender

ALL

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