Phase II study of ME3113 (ME3113-7)
- Conditions
- Benign prostatic hyperplasia with lower urinary tract symptoms
- Registration Number
- JPRN-jRCT2080222623
- Lead Sponsor
- Meiji Seika Pharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Male
- Target Recruitment
- 450
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in total score of International Prostate Symptom Score (IPSS)
- Secondary Outcome Measures
Name Time Method Change from baseline in the IPSS Quality of Life (QOL) Index