Effects and Safety of OPK-88004 Doses in Men With Signs and Symptoms of Benign Prostatic Hyperplasia (BPH)



Status:Recruiting
Conditions:Hematology, Benign Prostate Hyperplasia, Urology
Therapuetic Areas:Hematology, Nephrology / Urology
Healthy:No
Age Range:45 - Any
Updated:4/26/2018
Start Date:February 21, 2018
End Date:December 2018
Contact:Jiao Kuang
Email:jkuang@transitiontherapeutics.com
Phone:416-260-7770

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

A Randomized, Double-blind, Placebo-controlled Dose-ranging Study of OPK-88004 Once-a-day Dosing for 16 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

This study will evaluate the safety and effectiveness of different doses of OPK-88004
compared to placebo on prostate size and related lower urinary tract symptoms (LUTS) in men
with benign prostatic hyperplasia (BPH).

This clinical trial is designed as a randomized, placebo-controlled, multi-center phase 2
trial to evaluate the efficacy and safety of OPK-88004 in men with benign prostatic
hyperplasia. Eligible subjects will be randomized into one of two OPK-88004 treatment groups
or a placebo group after a 4-week screening period. Subjects will have monthly visits over a
16- week treatment period and will be evaluated for the effect of OPK-88004 on prostate
volume and safety measures, as well as plasma levels of OPK-88004.

Inclusion Criteria:

- Male 45 yrs or older

- BPH diagnosis

- Lower urinary tract symptoms secondary to BPH

- Enlarged prostate

- Have not received prior treatment with 5-ARIs (finasteride, dutasteride)

Exclusion Criteria:

- Post void residual volume ≥200 mL

- Previous pelvic, urinary tract surgery or procedures (e.g. radical prostatectomy,
pelvic surgery for removal of malignancy, or bowel resection; radiotherapy, penile
implant surgery)

- Lower urinary tract malignancy, obstruction or trauma

- History or presence of prostatic carcinoma

- Current treatment with androgens, antiandrogens, estrogens, LHRH agonists/antagonists,
or anabolic steroids

- Current neurologic disease or condition associated with neurogenic bladder (e.g.
Parkinson's disease, multiple sclerosis)

- Current treatment with potent CYP3A4 inhibitors such as itraconazole or ritonavir
We found this trial at
15
sites
120 Medical Boulevard
Spring Hill, Florida 34609
?
mi
from
Spring Hill, FL
Click here to add this to my saved trials
1800 SW 1 ST #208
Miami, Florida 33135
?
mi
from
Miami, FL
Click here to add this to my saved trials
7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Anniston, Alabama 36207
?
mi
from
Anniston, AL
Click here to add this to my saved trials
Aventura, Florida 33180
?
mi
from
Aventura, FL
Click here to add this to my saved trials
Elkridge, Maryland
?
mi
from
Elkridge, MD
Click here to add this to my saved trials
Garden City, New York 11530
?
mi
from
Garden City, NY
Click here to add this to my saved trials
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Lincoln, California 95648
?
mi
from
Lincoln, CA
Click here to add this to my saved trials
2950 Magic View Drive
Meridian, Idaho 83642
?
mi
from
Meridian, ID
Click here to add this to my saved trials
New York, New York 10016
?
mi
from
New York, NY
Click here to add this to my saved trials
Sacramento, California
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Shreveport, Louisiana 71106
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
Tampa, Florida 33607
?
mi
from
Tampa, FL
Click here to add this to my saved trials
12626 Riverside Drive
Valley Village, California 91607
?
mi
from
Valley Village, CA
Click here to add this to my saved trials