NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
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
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