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

This study is currently recruiting participants.
Verified April 2014 by Nymox Corporation
Sponsor:
Information provided by (Responsible Party):
Nymox Corporation
ClinicalTrials.gov Identifier:
NCT01846793
First received: May 1, 2013
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Benign Prostatic Hyperplasia
BPH
Lower Urinary Tract Symptoms (LUTS)
LUTS
Enlarged Prostate
Drug: NX-1207
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Nymox Corporation:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 200
Study Start Date: April 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01846793

Contacts
Contact: There will be multiple sites for this clinical trial. For further information contact Nymox at 800-936-9669 or at info@nymox.com

Locations
United States, California
For information concerning this clinical site, please contact Nymox at 800-936-9669. Recruiting
Laguna Beach, California, United States, 92653
For information concerning this clinical site, please contact Nymox at 800-936-9669. Recruiting
San Diego, California, United States, 92120
United States, Florida
For information concerning this clinical site, please contact Nymox at 800-936-9669. Recruiting
Aventura, Florida, United States, 33180
For information concerning this clinical site, please contact Nymox at 800-936-9669. Recruiting
Naples, Florida, United States, 34102
United States, Idaho
For information concerning this clinical site, please contact Nymox at 800-936-9669. Recruiting
Meridian, Idaho, United States, 83642
United States, Indiana
For information concerning this clinical site, please contact Nymox at 800-936-9669. Recruiting
Jeffersonville, Indiana, United States, 47130
United States, Louisiana
For information concerning this clinical site, please contact Nymox at 800-936-9669. Recruiting
Shreveport, Louisiana, United States, 71106
United States, Maryland
For information concerning this clinical site, please contact Nymox at 800-936-9669. Recruiting
Annapolis, Maryland, United States, 21401
For information concerning this clinical site, please contact Nymox at 800-936-9669. Recruiting
Baltimore, Maryland, United States, 21237
For information concerning this clinical site, please contact Nymox at 800-936-9669. Recruiting
Glen Burnie, Maryland, United States, 21061
For information concerning this clinical site, please contact Nymox at 800-936-9669. Recruiting
Towson, Maryland, United States, 21204
United States, Montana
For information concerning this clinical site, please contact Nymox at 800-936-9669. Recruiting
Missoula, Montana, United States, 59808
United States, New Jersey
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Brick, New Jersey, United States, 08724
United States, New York
For information concerning this clinical site, please contact Nymox at 800-936-9669. Recruiting
Garden City, New York, United States, 11530
For information concerning this clinical site, please contact Nymox at 800-936-9669. Recruiting
New York, New York, United States, 10016
United States, Ohio
For information concerning this clinical site, please contact Nymox at 800-936-9669. Recruiting
Columbus, Ohio, United States, 43221
United States, Texas
For information concerning this clinical site, please contact Nymox at 800-936-9669. Recruiting
Dallas, Texas, United States, 75010
Sponsors and Collaborators
Nymox Corporation
  More Information

No publications provided

Responsible Party: Nymox Corporation
ClinicalTrials.gov Identifier: NCT01846793     History of Changes
Other Study ID Numbers: NX02-0022
Study First Received: May 1, 2013
Last Updated: April 1, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Nymox Corporation:
Lower urinary tract symptoms
Benign prostatic hyperplasia
BPH
Enlarged prostate
LUTS
LUTS secondary to BPH
LUTS/BPH
Benign prostatic obstruction (BPO)
BPO
Bladder outlet obstruction
BOO

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014