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

NCT ID: NCT01438775

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

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-01-31

Brief Summary

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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.

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 Lower urinary tract symptoms LUTS LUTS secondary to BPH LUTS/BPH Benign prostatic obstruction BPO Bladder outlet obstruction BOO

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open Label Injection of NX-1207

Intraprostatic injection of 2.5 mg NX-1207

Group Type EXPERIMENTAL

NX-1207

Intervention Type DRUG

2.5 mg NX-1207 in 10 mL saline vehicle

Interventions

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NX-1207

2.5 mg NX-1207 in 10 mL saline vehicle

Intervention Type DRUG

Eligibility Criteria

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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
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.

Huntsville, Alabama, United States

Site Status

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

Atherton, California, United States

Site Status

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San Diego, California, United States

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Tarzana, California, United States

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Denver, Colorado, United States

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Englewood, Colorado, United States

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New Britain, Connecticut, United States

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Sarasota, Florida, United States

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Meridian, Idaho, 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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Annapolis, Maryland, United States

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Southaven, Mississippi, United States

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Missoula, Montana, United States

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Lawrenceville, New Jersey, United States

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Albuquerque, New Mexico, 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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New York, 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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Bismarck, North Dakota, United States

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Lancaster, Pennsylvania, United States

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Memphis, Tennessee, United States

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Arlington, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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NX02-0020

Identifier Type: -

Identifier Source: org_study_id