NCT01002417

MCS in the Treatment of Lower Urinary Tract Symptoms

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 274 (actual)
• Sponsor: Health Ever Bio-Tech Co., Ltd. · Industry
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Lower Urinary Tract Symptoms
• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	MCS-2 15 mg/day	One MCS-2 15 mg soft-gel capsule plus one matching placebo capsule, oral daily for 12 weeks.
DRUG	MCS-2 30 mg/day	Two MCS-2 soft-gel capsules, oral daily for 12 weeks.
DRUG	Placebo	Two matching placebo soft-gel capsules, oral daily for 12 weeks.

Timeline

• Start date: 2010-07-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2009-10-27
• Last updated: 2015-03-03

Locations

1 site across 1 country: United States