Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01438775
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