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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01846793
Other study ID # NX02-0022
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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