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Placebo controlled, double - blind study of ME3113 in benign prostatic hyperplasia patients with lower urinary tract symptoms (Phase II)

Phase II study of ME3113 (ME3113-7)

Meiji Seika Pharma Co., Ltd.

e-mail: clinical_trials@meiji.com

Meiji Seika Pharma Co., Ltd.

e-mail: clinical_trials@meiji.com

Interventional

Multicenter, randomized, placebo controlled, double - blind, parallel group comparison study

2

BPH patients with LUTS for greater than 6 months.
Total International Prostate Symptom Score (IPSS) at the baseline visit is within a specific range.
etc.

Have taken the following treatments;
- Alpha blocker therapy, 5-alpha reductase inhibitor therapy, Anti-androgenic hormone therapy, All other BPH therapy, Over Active Bladder (OAB) therapy.
- Have experience of malignant tumor diseases within 5 years.
- Prostatic specific antigen (PSA) level is more than 10.0 ng/mL at study entry.
- History of cardiac diseases.
- Have evidences of cardiac diseases such as development of fatigue, palpitation, dyspnoea or angina pain.
- History of clinically significant drug sensitivity.
- Have complication or past history of nonarteritic anterior ischemic optic neuropathy (NAION).
- Have a complication or past history of retinal pigment degeneration.
- Planned to receive a surgery during the study period (any treatments requiring general anesthesia, spinal anesthesia or epidural anesthesia).
- Have taken any other study drug in clinical studies in the past 90 days.
- Previous administration of ME3113
- Have judged to be an inappropriate subject for this trial by the investigator or subinvestigator.
etc.

Male

Benign prostatic hyperplasia with lower urinary tract symptoms

investigational material(s)
Generic name etc : ME3113
INN of investigational material : Udenafil
Therapeutic category code : 259 Other agents for uro-genital and anal organ
Dosage and Administration for Investigational material : Oral

control material(s)
Generic name etc : Placebo
INN of investigational material :
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Oral

Change from baseline in total score of International Prostate Symptom Score (IPSS)

Change from baseline in the IPSS Quality of Life (QOL) Index