Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)(NX02-0022)



Status:Completed
Conditions:Prostate Cancer, Hematology, Benign Prostate Hyperplasia, Urology
Therapuetic Areas:Hematology, Nephrology / Urology, Oncology
Healthy:No
Age Range:45 - Any
Updated:3/11/2017
Start Date:April 2013
End Date:October 2014

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Phase 3 Multicenter Prospective Open Label Clinical Safety Evaluation of Re-Injection of NX-1207 for the Treatment of BPH: Two Doses 1-8 Years Apart

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.


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 (other than NX02-0020) 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.

- Prostate-Specific Antigen (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
We found this trial at
17
sites
664
mi
from 91732
Meridian, ID
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2309
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from 91732
Annapolis, MD
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2319
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Aventura, FL
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2301
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Baltimore, MD
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2430
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Brick, NJ
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1959
mi
from 91732
Columbus, OH
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1225
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Dallas, TX
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2452
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from 91732
Garden City, NY
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2301
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Glen Burnie, MD
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1814
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from 91732
Jeffersonville, IN
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38
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from 91732
Laguna Beach, CA
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910
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Missoula, MT
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2220
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Naples, FL
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2435
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New York, NY
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105
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San Diego, CA
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1401
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Shreveport, LA
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2300
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Towson, MD
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