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

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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
Anniston, Alabama 36207
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1800 SW 1 ST #208
Miami, Florida 33135
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Miami, FL
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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San Antonio, TX
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Aventura, Florida 33180
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Aventura, FL
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Elkridge, Maryland
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Elkridge, MD
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Garden City, New York 11530
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Garden City, NY
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Knoxville, TN
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Lincoln, California 95648
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Lincoln, CA
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2950 Magic View Drive
Meridian, Idaho 83642
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Meridian, ID
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New York, New York 10016
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New York, NY
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Sacramento, California
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Sacramento, CA
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Shreveport, Louisiana 71106
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Shreveport, LA
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120 Medical Boulevard
Spring Hill, Florida 34609
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Spring Hill, FL
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Tampa, Florida 33607
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Tampa, FL
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12626 Riverside Drive
Valley Village, California 91607
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Valley Village, CA
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