Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)(NX02-0022)
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ClinicalTrials.gov Identifier: NCT01846793 |
Recruitment Status :
Completed
First Posted : May 3, 2013
Last Update Posted : March 10, 2017
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Condition or disease | Intervention/treatment | Phase |
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Benign Prostatic Hyperplasia BPH Lower Urinary Tract Symptoms (LUTS) LUTS | Drug: NX-1207 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 160 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | April 2013 |
Actual Primary Completion Date : | October 2014 |
Actual Study Completion Date : | October 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Open Label Injection of NX-1207
Intraprostatic injection of 2.5 mg NX-1207
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Drug: NX-1207
2.5 mg NX-1207 in 10 mL saline vehicle |
- Safety [ Time Frame: 180 days ]Safety parameters as determined by Adverse Events, clinical laboratory test results, vital signs, physical exam and electrocardiogram (ECG).
- Symptomatic Improvement [ Time Frame: 90 days ]Symptomatic improvement as measured by the change in American Urological Association (AUA) Symptom Index from baseline at 90 days. The AUA Symptom Index is a standardized questionnaire that uses seven questions relating to associated BPH symptoms to provide an assessment of symptom severity on a scale from 0 (no symptoms) to 35 (most severe).
- Prostate Volume Change [ Time Frame: 90 days ]Change in prostate volume from baseline to 90 days as measured by transrectal ultrasonography
- Change in Urinary Peak Flow [ Time Frame: 90 days. ]Change in Urinary Peak Flow (Qmax) from baseline to 90 days as determined by urinary flow-rate recording (uroflowmetry).
- Symptomatic Improvement [ Time Frame: 180 days ]Symptomatic improvement as measured by the change in AUA Symptom Index from baseline at 180 days.

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Ages Eligible for Study: | 45 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01846793
United States, California | |
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Laguna Beach, California, United States, 92653 | |
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San Diego, California, United States, 92120 | |
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Aventura, Florida, United States, 33180 | |
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Naples, Florida, United States, 34102 | |
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Meridian, Idaho, United States, 83642 | |
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Jeffersonville, Indiana, United States, 47130 | |
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Shreveport, Louisiana, United States, 71106 | |
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Annapolis, Maryland, United States, 21401 | |
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Baltimore, Maryland, United States, 21237 | |
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Glen Burnie, Maryland, United States, 21061 | |
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Towson, Maryland, United States, 21204 | |
United States, Montana | |
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Missoula, Montana, United States, 59808 | |
United States, New Jersey | |
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Brick, New Jersey, United States, 08724 | |
United States, New York | |
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Garden City, New York, United States, 11530 | |
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New York, New York, United States, 10016 | |
United States, Ohio | |
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Columbus, Ohio, United States, 43221 | |
United States, Texas | |
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Dallas, Texas, United States, 75010 |
Responsible Party: | Nymox Corporation |
ClinicalTrials.gov Identifier: | NCT01846793 |
Other Study ID Numbers: |
NX02-0022 |
First Posted: | May 3, 2013 Key Record Dates |
Last Update Posted: | March 10, 2017 |
Last Verified: | March 2017 |
Benign prostatic hyperplasia BPH Lower urinary tract symptoms LUTS LUTS secondary to BPH |
LUTS/BPH Benign prostatic obstruction (BPO) BPO Bladder outlet obstruction BOO |
Prostatic Hyperplasia Hyperplasia Lower Urinary Tract Symptoms |
Pathologic Processes Prostatic Diseases Urological Manifestations |