Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)(NX02-0022)

Sponsor

Nymox Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT01846793

Collaborator

(none)

160

Enrollment

Locations

Arm

Duration (Months)

9.4

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia BPH Lower Urinary Tract Symptoms (LUTS) LUTS	Drug: NX-1207	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

160 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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 1-8 Years Apart

Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Open Label Injection of NX-1207 Intraprostatic injection of 2.5 mg NX-1207	Drug: NX-1207 2.5 mg NX-1207 in 10 mL saline vehicle

Arm

Intervention/Treatment

Experimental: Open Label Injection of NX-1207

Intraprostatic injection of 2.5 mg NX-1207

Drug: NX-1207

2.5 mg NX-1207 in 10 mL saline vehicle

Outcome Measures

Primary Outcome Measures

Safety [180 days]
Safety parameters as determined by Adverse Events, clinical laboratory test results, vital signs, physical exam and electrocardiogram (ECG).

Secondary Outcome Measures

Symptomatic Improvement [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 [90 days]
Change in prostate volume from baseline to 90 days as measured by transrectal ultrasonography
Change in Urinary Peak Flow [90 days.]
Change in Urinary Peak Flow (Qmax) from baseline to 90 days as determined by urinary flow-rate recording (uroflowmetry).
Symptomatic Improvement [180 days]
Symptomatic improvement as measured by the change in AUA Symptom Index from baseline at 180 days.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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 (other than NX02-0020) 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.
Prostate-Specific Antigen (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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Laguna Beach	California	United States	92653
2	For information concerning this clinical site, please contact Nymox at 800-936-9669.	San Diego	California	United States	92120
3	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Aventura	Florida	United States	33180
4	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Naples	Florida	United States	34102
5	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Meridian	Idaho	United States	83642
6	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Jeffersonville	Indiana	United States	47130
7	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Shreveport	Louisiana	United States	71106
8	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Annapolis	Maryland	United States	21401
9	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Baltimore	Maryland	United States	21237
10	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Glen Burnie	Maryland	United States	21061
11	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Towson	Maryland	United States	21204
12	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Missoula	Montana	United States	59808
13	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Brick	New Jersey	United States	08724
14	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Garden City	New York	United States	11530
15	For information concerning this clinical site, please contact Nymox at 800-936-9669.	New York	New York	United States	10016
16	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Columbus	Ohio	United States	43221
17	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Dallas	Texas	United States	75010