MCS in the Treatment of Lower Urinary Tract Symptoms

18:09 EDT 27th March 2015 | BioPortfolio

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.

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Lower Urinary Tract Symptoms

Intervention

MCS-2 15 mg/day, MCS-2 30 mg/day, Placebo

Location

David Geffen School of Medicine at UCLA
Los Angeles
California
United States
90095

Status

Completed

Source

Health Ever Bio-Tech Co., Ltd.

Results (where available)

View Results

Links

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Medical and Biotech [MESH] Definitions

Lower urinary tract symptom, such as slow urinary stream, associated with PROSTATIC HYPERPLASIA in older men.

A surgical specialty concerned with the study, diagnosis, and treatment of diseases of the urinary tract in both sexes, and the genital tract in the male. Common urological problems include urinary obstruction, URINARY INCONTINENCE, infections, and UROGENITAL NEOPLASMS.

Painful URINATION. It is often associated with infections of the lower URINARY TRACT.

A second-generation cephalosporin administered intravenously or intramuscularly. Its bactericidal action results from inhibition of cell wall synthesis. It is used for urinary tract infections, lower respiratory tract infections, and soft tissue and bone infections.

Properties, functions, and processes of the URINARY TRACT as a whole or of any of its parts.

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