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drugset / Trial / NCT02003742

Efficacy and Safety of a Single TRUS-guided Intraprostatic Injection of NX-1207 in Patients With LUTS Due to BPH

NCT02003742 ↗

Phase 3 Terminated 104 enrolled RECORDATI GROUP
RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of the this international, multicenter, randomised, single-blind, parallel group, Phase III study is to demonstrate that a single transrectal ultrasound (TRUS)-guided intraprostatic injection of NX-1207 provides a long lasting therapeutic improvement of Lower Urinary Tract Symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH) in patients not adequately controlled by medical therapy with α-blockers, as assessed by a change from baseline in the International Prostate Symptom Score (IPSS) total score.

Timeline

Start
2013-09
Primary completion
2015-01-29
Completion
2015-01-29

Drugs

EvaluationDrugModalityDoseRoute
Subject FEXAPOTIDE Protein / enzyme biologic 2.5 mg Other
Comparator Tamsulosin Other / unclassified 0.4 mg Oral

Indications

No indication recorded.