Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)

April 1, 2014 updated by: Nymox Corporation

Phase III Multicenter Prospective Randomized Parallel-Group Placebo-Controlled Double Blind Clinical Evaluation of NX-1207 for the Treatment of BPH NX02-0017

This study will evaluate the safety and efficacy of a 2.5 mg dose of NX-1207 for the treatment of BPH (benign prostatic hyperplasia) as compared to placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

500

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
      • Birmingham, Alabama, United States, 35209
        • For information concerning this clinical site, please contact Nymox at 800-936-9669
      • Huntsville, Alabama, United States, 35801
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • Arizona
      • Tucson, Arizona, United States, 85712
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • California
      • Anaheim, California, United States, 92801
        • 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.
      • La Mesa, California, United States, 91942
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
      • Long Beach, California, United States, 90806
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
      • Los Alamitos, California, United States, 90720
        • 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.
    • Connecticut
      • New Britain, Connecticut, United States, 06052
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • Florida
      • Naples, Florida, United States, 34102
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
      • Ocala, Florida, United States, 34474
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
      • Orlando, Florida, United States, 32806
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
      • Tallahassee, Florida, United States, 32308
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • For information concerning this clinical site, please contact Nymox at 800-936-9669
      • Roswell, Georgia, United States, 30076
        • 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.
    • Montana
      • Missoula, Montana, United States, 59802
        • 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.
      • Mt. Laurel, New Jersey, United States, 08054
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
      • Voorhees, New Jersey, United States, 08043
        • 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.
      • 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.
      • Raleigh, North Carolina, United States, 27607
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
      • Columbus, Ohio, United States, 43221
        • For information concerning this clinical site, please contact Nymox at 800-936-9669
    • Oklahoma
      • Bethany, Oklahoma, United States, 73008
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • Oregon
      • Salem, Oregon, United States, 97301
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • Pennsylvania
      • Bala Cynwyd, Pennsylvania, United States, 19004
        • For information concerning this clinical site, please contact Nymox at 800-936-9669
      • Lancaster, Pennsylvania, United States, 17604
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • 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.
      • Carrollton, Texas, United States, 75010
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
      • Dallas, Texas, United States, 75231
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • 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:

  1. Provide signed informed consent prior to enrolment in the study
  2. IPSS ≥ 15
  3. Prostate Volume ≥ 30 mL ≤ 70 mL
  4. Qmax < 15 mL/sec based on a minimum void of 125 mL
  5. Agree not to use any other approved or experimental BPH or OAB medication anytime during the study

Exclusion Criteria:

  1. History of illness or condition that may interfere with study or endanger subject
  2. Use of prescribed medications that may interfere with study or endanger subject
  3. Presence of a median lobe of the prostate
  4. Previous surgery or MIST for treatment of BPH
  5. Post-void residual urine volume > 200 mL
  6. PSA ≥ 10 ng/mL; prostate cancer must be ruled out (negative biopsy) for PSA ≥ 4 ng/mL
  7. Participation in a study of any investigational drug or device within the previous 90 days
  8. Prostate cancer

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Single intraprostatic injection of placebo
Experimental: NX-1207
Drug: NX-1207
Single intraprostatic injection of 2.5 mg NX-1207

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
International Prostate Symptom Score (IPSS)
Time Frame: 365 days
365 days

Secondary Outcome Measures

Outcome Measure
Time Frame
International Prostate Symptom Score (IPSS)
Time Frame: 90 days
90 days
International Prostate Symptom Score (IPSS)
Time Frame: 180 days
180 days
International Prostate Symptom Score (IPSS)
Time Frame: 270 days
270 days
Peak urine flow rate (Qmax)
Time Frame: 365 days
365 days
Peak urine flow rate (Qmax)
Time Frame: 90 days
90 days
Peak urine flow rate (Qmax)
Time Frame: 180 days
180 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

April 1, 2009

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

June 9, 2009

First Submitted That Met QC Criteria

June 10, 2009

First Posted (Estimate)

June 11, 2009

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

  • NX02-0017

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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