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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-500863-10-00 | Other Identifier | EU CT |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NGI226 | Experimental | single peritendon injection |
|
| Placebo | Placebo Comparator | single peritendon injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NGI226 | Drug | NGI226 MP |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with AEs and SAEs | AEs and SAEs including ECG parameters, Lab Chemistry and Hematology parameters, urinalysis, local tolerability | Up to Day 169 (End of Study) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in tendon stiffness from baseline at week 12 assessed by ultrasound (US)-based shear wave elastography (SWE) | To assess the effects of a single peritendon injection of NGI226 MP versus placebo on restoration of biomechanical integrity of Achilles tendon | Baseline, Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson Orthopedic Institute PC | Tucson | Arizona | 85712 | United States | ||
| Advanced Research LLC |
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| Drug |
Placebo MP |
|
| Deerfield Beach |
| Florida |
| 33064 |
| United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| Novartis Investigative Site | Caluire-et-Cuire | 69300 | France |
| Novartis Investigative Site | Berlin | 10117 | Germany |
| Novartis Investigative Site | Hamburg | 20149 | Germany |
| Novartis Investigative Site | Hamburg | 22415 | Germany |