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

Use our guide to learn which trials are right for you!

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.


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
221
mi
from 02139
Brick, NJ
Click here to add this to my saved trials
140
mi
from 02139
Albany, NY
Click here to add this to my saved trials
1965
mi
from 02139
Albuquerque, NM
Click here to add this to my saved trials
365
mi
from 02139
Annapolis, MD
Click here to add this to my saved trials
1243
mi
from 02139
Aventura, FL
Click here to add this to my saved trials
357
mi
from 02139
Baltimore, MD
Click here to add this to my saved trials
1482
mi
from 02139
Bismarck, ND
Click here to add this to my saved trials
487
mi
from 02139
Bryn Mawr, PA
Click here to add this to my saved trials
1763
mi
from 02139
Denver, CO
Click here to add this to my saved trials
1765
mi
from 02139
Englewood, CO
Click here to add this to my saved trials
173
mi
from 02139
Garden City, NY
Click here to add this to my saved trials
363
mi
from 02139
Glen Burnie, MD
Click here to add this to my saved trials
739
mi
from 02139
Grand Rapids, MI
Click here to add this to my saved trials
1601
mi
from 02139
Houston, TX
Click here to add this to my saved trials
2575
mi
from 02139
Laguna Hills, CA
Click here to add this to my saved trials
2377
mi
from 02139
Las Vegas, NV
Click here to add this to my saved trials
1895
mi
from 02139
McAllen, TX
Click here to add this to my saved trials
1132
mi
from 02139
Memphis, TN
Click here to add this to my saved trials
2261
mi
from 02139
Meridian, ID
Click here to add this to my saved trials
180
mi
from 02139
New York, NY
Click here to add this to my saved trials
1098
mi
from 02139
Ocala, FL
Click here to add this to my saved trials
1490
mi
from 02139
Oklahoma City, OK
Click here to add this to my saved trials
1112
mi
from 02139
Orlando, FL
Click here to add this to my saved trials
469
mi
from 02139
Richmond, VA
Click here to add this to my saved trials
1769
mi
from 02139
San Antonio, TX
Click here to add this to my saved trials
2576
mi
from 02139
San Diego, CA
Click here to add this to my saved trials
1222
mi
from 02139
Sarasota, FL
Click here to add this to my saved trials
1166
mi
from 02139
Sartell, MN
Click here to add this to my saved trials
486
mi
from 02139
Sewickley, PA
Click here to add this to my saved trials
1136
mi
from 02139
Southaven, MS
Click here to add this to my saved trials
2600
mi
from 02139
Tarzana, CA
Click here to add this to my saved trials
2600
mi
from 02139
Torrance, CA
Click here to add this to my saved trials
353
mi
from 02139
Towson, MD
Click here to add this to my saved trials