Phase 2 Study of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) (Enlarged Prostate)

June 12, 2012 updated by: Nymox Corporation

Phase 2 Multicenter Randomized Two Dose Level and Non-Inferiority Clinical Evaluation of Transrectal Administration of NX-1207 for the Treatment of BPH

This completed study evaluated the safety and efficacy of two dose levels of NX-1207 for the treatment of BPH (benign prostatic hyperplasia) versus finasteride.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects randomized to NX-1207 were blinded as to the dose level of NX-1207 they received.

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Phase 2

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
        • Nymox Investigational Site
    • Arizona
      • Tucson, Arizona, United States
        • Nymox Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States
        • Nymox Investigational Site
    • California
      • Anaheim, California, United States
        • Nymox Investigational Site
      • Atherton, California, United States
        • Nymox Investigational Site
      • Long Beach, California, United States
        • Nymox Investigational Site
      • Modesto, California, United States
        • Nymox Investigational Site
      • Newport Beach, California, United States
        • Nymox Investigational Site
    • Colorado
      • Denver, Colorado, United States
        • Nymox Investigational Site
    • Connecticut
      • New Britain, Connecticut, United States
        • Nymox Investigational Site
    • Florida
      • Sarasota, Florida, United States
        • Nymox Investigational Site
    • Indiana
      • Greenwood, Indiana, United States
        • Nymox Investigational Site
      • Jeffersonville, Indiana, United States
        • Nymox Investigational Site
    • Louisiana
      • Shreveport, Louisiana, United States
        • Nymox Investigational Site
    • Montana
      • Missoula, Montana, United States
        • Nymox Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States
        • Nymox Investigational Site
    • New Jersey
      • Lawrenceville, New Jersey, United States
        • Nymox Investigational Site
      • Marlton, New Jersey, United States
        • Nymox Investigational Site
      • Voorhees, New Jersey, United States
        • Nymox Investigational Site
    • New York
      • Garden City, New York, United States
        • Nymox Investigational Site
      • Poughkeepsie, New York, United States
        • Nymox Investigational Site
      • Staten Island, New York, United States
        • Nymox Investigational Site
    • Pennsylvania
      • Lancaster, Pennsylvania, United States
        • Nymox Investigational Site
    • South Carolina
      • Myrtle Beach, South Carolina, United States
        • Nymox Investigational Site
    • Tennessee
      • Germantown, Tennessee, United States
        • Nymox Investigational Site
    • Texas
      • Arlington, Texas, United States
        • Nymox Investigational Site
      • Brownsville, Texas, United States
        • Nymox Investigational Site
      • Dallas, Texas, United States
        • Nymox Investigational Site
      • McAllen, Texas, United States
        • Nymox Investigational Site
      • San Antonio, Texas, United States
        • Nymox Investigational Site

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 to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Documented history of BPH for at least 1 year
  2. AUA SI ≥ 15
  3. Prostate Volume ≥ 30 mL ≤ 70 mL
  4. Qmax < 15 mL/sec

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. Surgery or MIST in the previous 12 months for treatment of BPH
  5. Post-void residual urine volume > 350 mL
  6. PSA ≥ 10 ng/mL; prostate cancer must be ruled out for PSA ≥ 4 ng/mL

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Single therapeutic dose of 2.5 mg NX-1207
Drug: 2.5 mg NX-1207
Therapeutic dose; single intraprostatic injection of 2.5 mg NX-1207
EXPERIMENTAL: 2
Single low dose of 0.125 mg NX-1207 for dose-response evaluation
Drug: 0.125 mg NX-1207
Low dose; single intraprostatic injection of 0.125 mg NX-1207
ACTIVE_COMPARATOR: 3
5.0 mg finasteride q.d.
Drug: finasteride
Active comparator; 5.0 mg finasteride p.o. q.d. for duration of study (180 days)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in BPH Symptom Score (AUA SI)
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Prostate Volume
Time Frame: 90 days
90 days
Change in Qmax
Time Frame: 90 days
90 days
Change in BPH Symptom Score (AUA SI)
Time Frame: 30 days
30 days
Change in BPH Symptom Score (AUA SI)
Time Frame: 180 days
180 days
Number of Participants with Adverse Events, duration and severity of Adverse Events and relation, if any, to drug
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

May 1, 2007

Primary Completion (ACTUAL)

January 1, 2008

Study Completion (ACTUAL)

May 1, 2008

Study Registration Dates

First Submitted

September 23, 2008

First Submitted That Met QC Criteria

September 24, 2008

First Posted (ESTIMATE)

September 25, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 14, 2012

Last Update Submitted That Met QC Criteria

June 12, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NX02-0016

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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