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

NCT02003742 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2022-05-26

No results posted yet for this study

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

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

Sponsors & Collaborators

  • RECORDATI GROUP

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-01-29
Completion
2015-01-29

Countries

  • Germany
  • Italy
  • Poland
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02003742 on ClinicalTrials.gov