drugset / Trial / NCT00945490

Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) NX02-0018

NCT00945490 ↗

Phase 3 Completed 500 enrolled Nymox Corporation
RandomizedParallel-groupTriple-blindTreatment

Summary

This study will evaluate the safety and efficacy of a 2.5 mg dose of NX-1207 for the treatment of BPH (benign prostatic hyperplasia) as compared to placebo.

Timeline

Start
2009-05
Primary completion
2014-05
Completion
2014-05

Outcome

Mixed primary results

release “the Company’s two Phase 3 U.S. studies of NX-1207 for the treatment of BPH, NX02-0017 and NX02-0018, failed to meet their primary efficacy endpoints.” nymox.com ↗

release “NX02-0017 and NX02-0018 of fexapotide triflutate (NX-1207) for BP H have successfully met the pre- specified primary endpoint” nymox.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject FEXAPOTIDE Protein / enzyme biologic 2.5 mg Other