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

April 1, 2014 updated by: Nymox Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

192

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • California
      • 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
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • Colorado
      • Denver, Colorado, United States, 80211
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
      • Englewood, Colorado, United States, 80113
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • Connecticut
      • New Britain, Connecticut, United States, 06052
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • Florida
      • Sarasota, Florida, United States, 34237
        • For information concerning this clinical site, please contact Nymox at 800-936-9669
    • Idaho
      • Meridian, Idaho, United States, 83642
        • For information concerning this clinical site, please contact Nymox at 800-936-9669
    • Indiana
      • Jeffersonville, Indiana, United States, 47130
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
      • Newburg, Indiana, United States, 47630
        • For information concerning this clinical site, please contact Nymox at 800-936-9669
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • For information concerning this clinical site, please contact Nymox at 800-936-9669
    • Mississippi
      • Southaven, Mississippi, United States, 38671
        • For information concerning this clinical site, please contact Nymox at 800-936-9669
    • Montana
      • Missoula, Montana, United States, 59808
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • New York
      • 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
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • North Carolina
      • Concord, North Carolina, United States, 28025
        • For information concerning this clinical site, please contact Nymox at 800-936-9669
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • For information concerning this clinical site, please contact Nymox at 800-936-9669
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17604
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • Texas
      • 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
        • For information concerning this clinical site, please contact Nymox at 800-936-9669

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 180 days
Safety parameters as determined by Adverse Events, clinical laboratory test results, vital signs, physical exam and electrocardiogram (ECG).
180 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
90 days
Prostate Volume Change
Time Frame: 90 days
Change in prostate volume from baseline to 90 days as measured by transrectal ultrasonography
90 days
Symptomatic Improvement
Time Frame: 180 days
Symptomatic improvement as measured by the change in AUA Symptom Index from baseline at 180 days.
180 days
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).
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nymox Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

September 20, 2011

First Submitted That Met QC Criteria

September 21, 2011

First Posted (ESTIMATE)

September 22, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

April 30, 2014

Last Update Submitted That Met QC Criteria

April 1, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NX02-0020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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