A study to investigate the safety, tolerability and preliminary efficacy of NGI226 microparticles in patients with Achilles tendinopathy

Phase 1

Recruiting

• Conditions: Achilles Tendinopathy; MedDRA version: 20.1Level: LLTClassification code: 10080130Term: Tendinopathy Class: 10028395; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: CTIS2022-500863-10-00
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-12
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Written informed consent prior to all study specific screening procedures must be obtained, Adults 30 to 70 years of age (both inclusive), 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 (Magnetic Resonance Imaging) diagnosed mid-portion Achilles tendinopathy, Symptoms present =8 weeks but <12 months, Achilles tendinopathy must have been refractory to at least 6 weeks of conservative treatment (physiotherapy, NSAIDs (Non Steroidal Anti Inflammatory Drugs), Rest Ice Compression Elevation (RICE))

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified