Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Nymox Corporation

ClinicalTrials.gov Identifier:

NCT01438775

First received: September 20, 2011

Last updated: April 23, 2013

Last verified: April 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	September 20, 2011
Last Updated Date	April 23, 2013
Start Date ^ICMJE	September 2011
Primary Completion Date	January 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 1, 2012)	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).
Original Primary Outcome Measures ^ICMJE (submitted: September 21, 2011)	Safety [ Time Frame: 90 days ] [ Designated as safety issue: Yes ] Safety parameters as determined by Adverse Events, clinical laboratory test results, vital signs, physical exam and ECG.
Change History	Complete list of historical versions of study NCT01438775 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 1, 2012)	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.
Original Secondary Outcome Measures ^ICMJE (submitted: September 21, 2011)	Symptomatic Improvement [ Time Frame: 90 days ] [ Designated as safety issue: No ] Symptomatic improvement as measured by the change in 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).
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Benign Prostatic Hyperplasia
Intervention ^ICMJE	Drug: NX-1207 2.5 mg NX-1207 in 10 mL saline vehicle
Study Arm (s)	Experimental: Open Label Injection of NX-1207 Intraprostatic injection of 2.5 mg NX-1207 Intervention: Drug: NX-1207
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	250
Estimated Completion Date	November 2013
Primary Completion Date	January 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Be male aged 45 or older. Sign an informed consent form. Be in good health. Received NX-1207 in a previous completed study or received NX-1207 or placebo in a concurrent U.S. study (NX02-0017 and NX02-0018) and completed their V10 (365 day) visit. Have Prostate Gland Volume ≥ 25 mL (25 g). Exclusion Criteria: Surgery or minimally invasive surgical therapy (MIST) for treatment of BPH after first NX-1207 injection Post-void residual urine volume > 200 mL Presence of a symptomatic median lobe of the prostate History of use of self-catheterization for urinary retention. Urinary retention in the previous 12 months. Prostatitis Urinary tract infection more than once in the past 12 months Prostate or bladder cancer. PSA ≥10 ng/mL Poorly controlled diabetes History or evidence of illness or condition that may interfere with study or endanger subject Participation in a study of any investigational drug (other than NX-1207) or investigational device within the previous 90 days Use of specific prescribed medications that may interfere with study or endanger subject
Gender	Male
Ages	45 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01438775
Other Study ID Numbers ^ICMJE	NX02-0020
Has Data Monitoring Committee	No
Responsible Party	Nymox Corporation
Study Sponsor ^ICMJE	Nymox Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Nymox Corporation
Verification Date	April 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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