Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) NX02-0018
Status: | Completed |
---|---|
Conditions: | Orthopedic, Hematology, Urology |
Therapuetic Areas: | Hematology, Nephrology / Urology, Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 45 - Any |
Updated: | 3/11/2017 |
Start Date: | May 2009 |
End Date: | May 2014 |
Phase III Multicenter Prospective Randomized Parallel-Group Placebo-Controlled Double Blind Clinical Evaluation of NX-1207 for the Treatment of BPH NX02-0018
This study will evaluate the safety and efficacy of a 2.5 mg dose of NX-1207 for the
treatment of BPH (benign prostatic hyperplasia) as compared to placebo.
treatment of BPH (benign prostatic hyperplasia) as compared to placebo.
Inclusion Criteria:
1. Provide signed informed consent prior to enrolment in the study
2. AUASI ≥ 15
3. Prostate Volume ≥ 30 mL ≤ 70 mL
4. Qmax < 15 mL/sec based on a minimum void of 125 mL
5. Agree not to use any other approved or experimental BPH or OAB medication anytime
during the study
Exclusion Criteria:
1. History of illness or condition that may interfere with study or endanger subject
2. Use of prescribed medications that may interfere with study or endanger subject
3. Presence of a median lobe of the prostate
4. Previous surgery or MIST for treatment of BPH
5. Post-void residual urine volume > 200 mL
6. PSA ≥ 10 ng/mL; prostate cancer must be ruled out (negative biopsy) for PSA ≥ 4 ng/mL
7. Participation in a study of any investigational drug or device within the previous 90
days
8. Prostate cancer
We found this trial at
33
sites
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