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

Benign Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01846793
• Other study ID #: NX02-0022
• Status: Completed
• Phase: Phase 3
• First received: May 1, 2013
• Last updated: March 9, 2017
• Start date: April 2013
• Est. completion date: October 2014

Study information

• Verified date: March 2017
• Source: Nymox Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• BPH
• Hyperplasia
• Lower Urinary Tract Symptoms
• Lower Urinary Tract Symptoms (LUTS)
• LUTS
• Prostatic Hyperplasia

Intervention

Drug:
• NX-1207
2.5 mg NX-1207 in 10 mL saline vehicle

Locations

Country	Name	City	State
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Annapolis	Maryland
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Aventura	Florida
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Baltimore	Maryland
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Brick	New Jersey
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Columbus	Ohio
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Dallas	Texas
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Garden City	New York
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Glen Burnie	Maryland
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Jeffersonville	Indiana
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Laguna Beach	California
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Meridian	Idaho
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Missoula	Montana
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Naples	Florida
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	New York	New York
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	San Diego	California
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Shreveport	Louisiana
United States	For information concerning this clinical site, please contact Nymox at 800-936-9669.	Towson	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Nymox Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Safety parameters as determined by Adverse Events, clinical laboratory test results, vital signs, physical exam and electrocardiogram (ECG).	180 days
Secondary	Symptomatic Improvement	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).	90 days
Secondary	Prostate Volume Change	Change in prostate volume from baseline to 90 days as measured by transrectal ultrasonography	90 days
Secondary	Change in Urinary Peak Flow	Change in Urinary Peak Flow (Qmax) from baseline to 90 days as determined by urinary flow-rate recording (uroflowmetry).	90 days.
Secondary	Symptomatic Improvement	Symptomatic improvement as measured by the change in AUA Symptom Index from baseline at 180 days.	180 days