Effects and Safety of OPK-88004 Doses in Men With Signs and Symptoms of Benign Prostatic Hyperplasia (BPH)
- Conditions
- Benign Prostatic Hyperplasia
- Interventions
- Other: PlaceboDrug: Group-1 (15mg, OPK-88004)Drug: Group-2 (25 mg,OPK-88004)
- Registration Number
- NCT03297398
- Lead Sponsor
- OPKO Health, Inc.
- Brief Summary
This study will evaluate the safety and effectiveness of different doses of OPK-88004 compared to placebo on serum PSA compared to placebo in men with benign prostatic hyperplasia (BPH).
- Detailed Description
Study SAR-202 is a phase 2 multicenter, placebo-controlled, double-blind trial to evaluate the effect of OPK-88004 doses (OPK-88004 15 mg, or OPK-88004 25 mg) on serum PSA compared to placebo in men with BPH. Approximately 115 men with BPH will be enrolled in the study, randomized 1:1:1 across three arms (placebo, OPK-88004 15 mg, or OPK-88004 25 mg). The trial will be conducted at approximately up to 35 sites within the US.
The study duration for individual subjects will be up to 24 weeks and will include three phases:
* a screening period (up to 4 weeks, including 1-week washout if required),
* a treatment period (16 weeks), and
* a follow-up period (4 weeks) Subjects will be randomized and receive their first dose of study drug at visit 2. They will begin the once daily oral dosing regimen and return every 4 weeks to the study site during the 16-week treatment period. Assessments during the study period will include vital signs, laboratory testing, weight, adverse events (AEs), concomitant drugs, and study drug compliance. Efficacy assessments will include serum PSA, LBM and fat mass by DXA scans, uroflowmetry parameters, PVR (by ultrasound), and assessment of symptoms by IPSS.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 114
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Other Placebo Placebo Group Drug Group 1 Group-1 (15mg, OPK-88004) 15mg, OPK-88004 Drug Group 2 Group-2 (25 mg,OPK-88004) 25,mg OPK-88004
- Primary Outcome Measures
Name Time Method Change From Baseline in PSA (%) to Week 16 16 weeks The trial will evaluate the effect of two doses of OPK-88004 (15 mg and 25 mg) daily for 16 weeks on serum PSA compared with placebo
- Secondary Outcome Measures
Name Time Method Absolute Change in Lean Body Mass and Fat Mass From Baseline to 16 Weeks 16 weeks To assess the effect of OPK-88004 on body composition by DXA, specifically Lean Body Mass (LBM) and fat mass
Related Research Topics
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Trial Locations
- Locations (15)
APF Research, LLC
🇺🇸Miami, Florida, United States
Meridien Research - Brooksville
🇺🇸Spring Hill, Florida, United States
Florida Urology Partners
🇺🇸Tampa, Florida, United States
Pinnacle Research Group
🇺🇸Anniston, Alabama, United States
Volunteer Research Group and New Orleans Center for Clinical Research - Knoxville
🇺🇸Knoxville, Tennessee, United States
Northern California Research
🇺🇸Sacramento, California, United States
AccuMed Research Associates
🇺🇸Garden City, New York, United States
South Florida Medical Research
🇺🇸Aventura, Florida, United States
Regional Urology
🇺🇸Shreveport, Louisiana, United States
Clinical Trials Research
🇺🇸Lincoln, California, United States
Bayview Research Group, LLC - Valley Village
🇺🇸Valley Village, California, United States
Centennial Medical Group
🇺🇸Elkridge, Maryland, United States
Advanced Clinical Research - Boise
🇺🇸Meridian, Idaho, United States
Manhattan Medical Research Practice PLLC
🇺🇸New York, New York, United States
Clinical Trials of Texas, Inc.
🇺🇸San Antonio, Texas, United States