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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01846793
Recruitment Status : Completed
First Posted : May 3, 2013
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Nymox Corporation

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : April 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. Safety [ Time Frame: 180 days ]
    Safety parameters as determined by Adverse Events, clinical laboratory test results, vital signs, physical exam and electrocardiogram (ECG).


Secondary Outcome Measures :
  1. Symptomatic Improvement [ Time Frame: 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).

  2. Prostate Volume Change [ Time Frame: 90 days ]
    Change in prostate volume from baseline to 90 days as measured by transrectal ultrasonography

  3. Change in Urinary Peak Flow [ Time Frame: 90 days. ]
    Change in Urinary Peak Flow (Qmax) from baseline to 90 days as determined by urinary flow-rate recording (uroflowmetry).

  4. Symptomatic Improvement [ Time Frame: 180 days ]
    Symptomatic improvement as measured by the change in AUA Symptom Index from baseline at 180 days.


Eligibility Criteria
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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01846793


Locations
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United States, California
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Laguna Beach, California, United States, 92653
For information concerning this clinical site, please contact Nymox at 800-936-9669.
San Diego, California, United States, 92120
United States, Florida
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Aventura, Florida, United States, 33180
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Naples, Florida, United States, 34102
United States, Idaho
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Meridian, Idaho, United States, 83642
United States, Indiana
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Jeffersonville, Indiana, United States, 47130
United States, Louisiana
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Shreveport, Louisiana, United States, 71106
United States, Maryland
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Annapolis, Maryland, United States, 21401
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Baltimore, Maryland, United States, 21237
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Glen Burnie, Maryland, United States, 21061
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Towson, Maryland, United States, 21204
United States, Montana
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Missoula, Montana, United States, 59808
United States, New Jersey
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Brick, New Jersey, United States, 08724
United States, New York
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Garden City, New York, United States, 11530
For information concerning this clinical site, please contact Nymox at 800-936-9669.
New York, New York, United States, 10016
United States, Ohio
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Columbus, Ohio, United States, 43221
United States, Texas
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Dallas, Texas, United States, 75010
Sponsors and Collaborators
Nymox Corporation
More Information
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Responsible Party: Nymox Corporation
ClinicalTrials.gov Identifier: NCT01846793    
Other Study ID Numbers: NX02-0022
First Posted: May 3, 2013    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017
Keywords provided by Nymox Corporation:
Benign prostatic hyperplasia
BPH
Lower urinary tract symptoms
LUTS
LUTS secondary to BPH
 LUTS/BPH
Benign prostatic obstruction (BPO)
BPO
Bladder outlet obstruction
BOO
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Lower Urinary Tract Symptoms
Pathologic Processes
 Prostatic Diseases
Genital Diseases, Male
Urological Manifestations
Signs and Symptoms