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 |
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.
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
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