drugset / Trial / NCT04469270

Study to Assess Safety and Efficacy of Engensis in Painful Diabetic Peripheral Neuropathy

NCT04469270 ↗

Phase 3 Completed 162 enrolled Helixmith Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of intramuscular administration of Engensis on pain in participants with painful diabetic peripheral neuropathy in the feet and lower legs, as compared to Placebo, as a second Phase 3, well controlled study, sufficient in supporting the efficacy and safety of Engensis.

Timeline

Start
2020-11-20
Primary completion
2023-03-24
Completion
2024-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Engensis Other / unclassified 0.25 mg Intramuscular
Subject Engensis Other / unclassified 0.5 ml Intramuscular