Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)
This study is designed to demonstrate the safety and efficacy of a second transrectal intraprostatic injection of NX-1207 given to subjects with Benign Prostatic Hyperplasia (BPH) who previously received an injection of NX-1207 in an earlier U.S. clinical trial of NX-1207.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 3 Multicenter Prospective Open Label Clinical Safety Evaluation of Re-Injection of NX-1207 for the Treatment of BPH: Two Doses 1-7 Years Apart|
- Safety [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]Safety parameters as determined by Adverse Events, clinical laboratory test results, vital signs, physical exam and electrocardiogram (ECG).
- Symptomatic Improvement [ Time Frame: 90 days ] [ Designated as safety issue: No ]Symptomatic improvement as measured by the change in American Urological Association (AUA) Symptom Index from baseline at 90 days. The AUA Symptom Index is a standardized questionnaire that uses seven questions relating to associated BPH symptoms to provide an assessment of symptom severity on a scale from 0 (no symptoms) to 35 (most severe).
- Prostate Volume Change [ Time Frame: 90 days ] [ Designated as safety issue: No ]Change in prostate volume from baseline to 90 days as measured by transrectal ultrasonography
- Change in Urinary Peak Flow [ Time Frame: 90 days ] [ Designated as safety issue: No ]Change in Urinary Peak Flow (Qmax) from baseline to 90 days as determined by urinary flow-rate recording (uroflowmetry).
- Symptomatic Improvement [ Time Frame: 180 days ] [ Designated as safety issue: No ]Symptomatic improvement as measured by the change in AUA Symptom Index from baseline at 180 days.
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||November 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Experimental: Open Label Injection of NX-1207
Intraprostatic injection of 2.5 mg NX-1207
2.5 mg NX-1207 in 10 mL saline vehicle
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