NCT03297398

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: OPKO Health, Inc. · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	Group-1 (15mg, OPK-88004)	15mg, OPK-88004
DRUG	Group-2 (25 mg,OPK-88004)	25 mg,OPK-88004
OTHER	Placebo	Placebo

Timeline

• Start date: 2018-02-21
• Primary completion: 2019-04-18
• Completion: 2019-06-10
• First posted: 2017-09-29
• Last updated: 2021-09-16
• Results posted: 2021-07-28

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study