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

NCT ID: NCT00918983

Last Updated: 2014-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2013-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Benign Prostatic Hyperplasia

Keywords

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Benign prostatic hyperplasia BPH Enlarged prostate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NX-1207

Group Type EXPERIMENTAL

NX-1207

Intervention Type DRUG

Single intraprostatic injection of 2.5 mg NX-1207

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single intraprostatic injection of placebo

Interventions

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NX-1207

Single intraprostatic injection of 2.5 mg NX-1207

Intervention Type DRUG

Placebo

Single intraprostatic injection of placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Nymox Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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For information concerning this clinical site, please contact Nymox at 800-936-9669

Birmingham, Alabama, United States

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For information concerning this clinical site, please contact Nymox at 800-936-9669.

Huntsville, Alabama, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Anaheim, California, United States

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For information concerning this clinical site, please contact Nymox at 800-936-9669.

Atherton, California, United States

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La Mesa, California, United States

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Long Beach, California, United States

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Los Alamitos, California, United States

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Denver, Colorado, United States

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New Britain, Connecticut, United States

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Naples, Florida, United States

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Ocala, Florida, United States

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Orlando, Florida, United States

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Tallahassee, Florida, United States

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Atlanta, Georgia, United States

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Roswell, Georgia, United States

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Forest Hill, Indiana, United States

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Jeffersonville, Indiana, United States

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Shreveport, Louisiana, United States

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Missoula, Montana, United States

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Lawrenceville, New Jersey, United States

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Mount Laurel, New Jersey, United States

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Voorhees Township, New Jersey, United States

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Brooklyn, New York, United States

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Garden City, New York, United States

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Poughkeepsie, New York, United States

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Concord, North Carolina, United States

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Raleigh, North Carolina, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Bethany, Oklahoma, United States

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Salem, Oregon, United States

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Bala-Cynwyd, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Myrtle Beach, South Carolina, United States

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Knoxville, Tennessee, United States

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Arlington, Texas, United States

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Carrollton, Texas, United States

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Dallas, Texas, United States

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Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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NX02-0017

Identifier Type: -

Identifier Source: org_study_id