Benign prostatic hyperplasia with lower urinary tract symptoms
Conditions
Sponsors
Meiji Seika Pharma Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in total score of International Prostate Symptom Score (IPSS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in the IPSS Quality of Life (QOL) Index | — |
Outcome results
None listed