Phase 3TerminatedAge-related condition
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
- Sponsor
- RECORDATI GROUP (Industry)
- Enrollment
- 104 enrolled
- Conditions
- Lower Urinary Tract Symptoms
- Interventions
- NX-1207; Tamsulosin
- Ages
- adults, older adults
- Registry
- NCT02003742
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Change from baseline in the total IPSS score.
History
Last registry update
Primary completion
Registered
Started