Status:
COMPLETED
Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)(NX02-0022)
Lead Sponsor:
Nymox Corporation
Conditions:
Benign Prostatic Hyperplasia
BPH
Eligibility:
MALE
45+ years
Phase:
PHASE3
Brief Summary
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 recei...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT01846793
Start Date
April 1 2013
End Date
October 1 2014
Last Update
March 10 2017
Active Locations (17)
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1
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Laguna Beach, California, United States, 92653
2
For information concerning this clinical site, please contact Nymox at 800-936-9669.
San Diego, California, United States, 92120
3
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Aventura, Florida, United States, 33180
4
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Naples, Florida, United States, 34102