Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)
|ClinicalTrials.gov Identifier: NCT01438775|
Recruitment Status : Completed
First Posted : September 22, 2011
Last Update Posted : April 30, 2014
|Condition or disease||Intervention/treatment||Phase|
|Benign Prostatic Hyperplasia||Drug: NX-1207||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||192 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
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
- Safety [ Time Frame: 180 days ]Safety parameters as determined by Adverse Events, clinical laboratory test results, vital signs, physical exam and electrocardiogram (ECG).
- Symptomatic Improvement [ Time Frame: 90 days ]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 ]Change in prostate volume from baseline to 90 days as measured by transrectal ultrasonography
- Change in Urinary Peak Flow [ Time Frame: 90 days ]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 ]Symptomatic improvement as measured by the change in AUA Symptom Index from baseline at 180 days.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01438775
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