Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) NX02-0018

March 9, 2017 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 NX02-0018

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • California
      • Laguna Hills, California, United States, 92653
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
      • San Diego, California, United States, 92120
        • 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.
      • Torrance, California, United States, 90505
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • Colorado
      • Denver, Colorado, United States, 80220
        • 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.
    • Florida
      • Aventura, Florida, United States, 33180
        • 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, 32803
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
      • 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.
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
      • Baltimore, Maryland, United States, 21237
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
      • Glen Burnie, Maryland, United States, 21061
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
      • Towson, Maryland, United States, 21204
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • For information concerning this clinical site, please contact Nymox at 800-936-9669
    • Minnesota
      • Sartell, Minnesota, United States, 56377
        • 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.
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
      • Las Vegas, Nevada, United States, 89146
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • New Jersey
      • Brick, New Jersey, United States, 08724
        • 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
      • Albany, New York, United States, 12208
        • 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.
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, United States, 19010
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
      • Sewickley, Pennsylvania, United States, 15143
        • 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
      • Houston, Texas, United States, 77024
        • For information concerning this clinical site, please contact Nymox at 800-936-9669.
      • McAllen, Texas, United States, 78503
        • 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.
    • Virginia
      • Richmond, Virginia, United States, 23235
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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. AUASI ≥ 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: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
American Urological Association Symptom Index (AUASI)
Time Frame: 365 days
365 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
American Urological Association Symptom Index (AUASI)
Time Frame: 90 days
90 days
American Urological Association Symptom Index (AUASI)
Time Frame: 180 days
180 days
American Urological Association Symptom Index (AUASI)
Time Frame: 270 days
270 days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NX02-0018

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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Conditions

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