NCT02003742

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

Efficacy and Safety of a Single Transrectal Ultrasound(TRUS)-Guided Intraprostatic Injection of NX-1207 in Patients With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: A Phase III European Study

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: RECORDATI GROUP · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lower Urinary Tract Symptoms

Interventions

Type	Name	Description
DRUG	NX-1207	Single TRUS-guided intraprostatic injection of 2.5 mg of NX-1207
DRUG	Tamsulosin	1 film coated, prolonged release tablet of tamsulosin 0.4 mg, to be taken orally (p.o.) QD

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-01-29
• Completion: 2015-01-29
• First posted: 2013-12-06
• Last updated: 2022-05-26

Locations

5 sites across 5 countries: Germany, Italy, Poland, Spain, United Kingdom