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

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: NCT01438775
Recruitment Status : Completed
First Posted : September 22, 2011
Last Update Posted : April 30, 2014
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 Drug: NX-1207 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 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 1-7 Years Apart
Study Start Date : September 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

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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 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.
  • 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): NCT01438775


Locations
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United States, Alabama
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Huntsville, Alabama, United States, 35801
United States, California
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Atherton, California, United States, 94027
For information concerning this clinical site, please contact Nymox at 800-936-9669.
San Diego, California, United States, 92103
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Tarzana, California, United States, 91356
United States, Colorado
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Denver, Colorado, United States, 80211
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Englewood, Colorado, United States, 80113
United States, Connecticut
For information concerning this clinical site, please contact Nymox at 800-936-9669.
New Britain, Connecticut, United States, 06052
United States, Florida
For information concerning this clinical site, please contact Nymox at 800-936-9669
Sarasota, Florida, United States, 34237
United States, Idaho
For information concerning this clinical site, please contact Nymox at 800-936-9669
Meridian, Idaho, United States, 83642
United States, Indiana
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Jeffersonville, Indiana, United States, 47130
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Newburg, Indiana, United States, 47630
United States, Louisiana
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Shreveport, Louisiana, United States, 71106
United States, Maryland
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Annapolis, Maryland, United States, 21401
United States, Mississippi
For information concerning this clinical site, please contact Nymox at 800-936-9669
Southaven, Mississippi, United States, 38671
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.
Lawrenceville, New Jersey, United States, 08648
United States, New Mexico
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Albuquerque, New Mexico, United States, 87109
United States, New York
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Brooklyn, New York, United States, 11215
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
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Poughkeepsie, New York, United States, 12601
United States, North Carolina
For information concerning this clinical site, please contact Nymox at 800-936-9669
Concord, North Carolina, United States, 28025
United States, North Dakota
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Bismarck, North Dakota, United States, 58501
United States, Pennsylvania
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Lancaster, Pennsylvania, United States, 17604
United States, Tennessee
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Memphis, Tennessee, United States, 38119
United States, Texas
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Arlington, Texas, United States, 76017
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Houston, Texas, United States, 77024
For information concerning this clinical site, please contact Nymox at 800-936-9669
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Nymox Corporation
More Information
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Responsible Party: Nymox Corporation
ClinicalTrials.gov Identifier: NCT01438775    
Other Study ID Numbers: NX02-0020
First Posted: September 22, 2011    Key Record Dates
Last Update Posted: April 30, 2014
Last Verified: April 2014
Keywords provided by Nymox Corporation:
Benign prostatic hyperplasia
BPH
Enlarged prostate
Lower urinary tract symptoms
LUTS
LUTS secondary to BPH
 LUTS/BPH
Benign prostatic obstruction
BPO
Bladder outlet obstruction
BOO
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Male Urogenital Diseases