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An Adaptive, Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Study to Establish the Dosage, Efficacy, and Safety of MCS-2 in Treating Lower Urinary Tract Symptoms Suggestive of BPH in Treatment-Naive Male Subjects
The hypothesis of the study is to examine whether MCS-2 is safe and effective in the treatment of lower urinary tract symptoms suggestive of benign prostatic hyperplasia.
This is an adaptive trial design, that combines elements of a Phase 2b (dose ranging) study and a Phase 3 (hypothesis testing) study, the objectives for the two phases are separate. Phase 2b Objectives: The primary objective of the Phase 2b portion of this study is to evaluate, in a treatment-naïve population, the 0 mg (placebo), 15 mg, and 30 mg MCS-2 in terms of dose response and to determine the optimal dose to be used in the Phase 3 portion of this trial. The secondary objective of this portion of the study is to evaluate the safety and tolerability of the 15 mg and 30 mg MCS-2. Phase 3 Objectives: The primary objective of the Phase 3 portion of this study is to evaluate, in a treatment-naïve population, the effectiveness of the MCS-2 (at the dosage determined in the Phase 2b portion of this study), as compared to MCS placebo (0 mg), in reducing the lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). The secondary objective of this study is to evaluate the safety and tolerability of MCS-2 (at the dosage determined in the Phase 2b portion of this study), as compared to MCS placebo (0 mg).
Age
40 - No limit years
Sex
MALE
Healthy Volunteers
No
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
Start Date
July 1, 2010
Primary Completion Date
February 1, 2014
Completion Date
February 1, 2014
Last Updated
March 3, 2015
274
ACTUAL participants
MCS-2 15 mg/day
DRUG
MCS-2 30 mg/day
DRUG
Placebo
DRUG
Lead Sponsor
Health Ever Bio-Tech Co., Ltd.
NCT07451548
NCT07016620
NCT06312722
Data Source & Attribution
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