Advertisement

Topics

MCS in the Treatment of Lower Urinary Tract Symptoms

2015-03-27 05:38:42 | 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

Published on BioPortfolio: 2015-03-27T05:38:42-0400

Clinical Trials [1665 Associated Clinical Trials listed on BioPortfolio]

Efficacy and Safety of L-O-M® MCS in the Treatment of Lower Urinary Tract Symptoms

The hypothesis of the study is to examine whether L-O-M® Multi-Carotenoids (MCS) is safe and effective in the treatment of lower urinary tract symptoms suggestive of benign prostatic hype...

Lower Urinary Tract Infection (UTI) Evaluation in Women With Uterine Leiomyomata

To the investigators knowledge there is no research data published to date regarding the lower urinary tract symptoms in women with leiomyomas. The primary aims of this study are: 1. T...

Study to Evaluate Efficacy and Safety of NDS-446 in Men With Lower Urinary Tract Symptoms (LUTS)

Prospective, Randomized, Double-Blind, Placebo Controlled clinical trial to study the efficacy and the safety of NDS-446 (500 mg/cap) in Men 45 years of age or older with moderate to sever...

A Study of YM178 in Men With Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)

This study will examine the safety, tolerability, and efficacy of YM178 compared to placebo.

Lower Urinary Tract and Sexual Function in Women Following Surgery for Colorectal Disorders

This is a prevalence study evaluating lower urinary tract, prolapse, bowel, and sexual symptoms in women with a colorectal disorder who are planning to undergo surgery. The purpose of thi...

PubMed Articles [14459 Associated PubMed Articles listed on BioPortfolio]

Development and Initial Testing of the FLOW Instrument, a Novel Assessment of Lower Urinary Tract Symptoms in Men.

To develop a method of assessing lower urinary tract symptoms (LUTS) regardless of literacy/numeracy.

Degarelix Versus Goserelin Plus Bicalutamide in the Short-Term Relief of Lower Urinary Tract Symptoms in Prostate Cancer Patients: Results of a Pooled Analysis.

In patients with prostate cancer (PCa), prostate enlargement may give rise to lower urinary tract symptoms (LUTS); many patients suffer from moderate-to-severe symptoms. We compare the efficacy of deg...

Urodynamic Investigation: A Valid Tool to Define Normal Lower Urinary Tract Function?

To evaluate whether urodynamic investigation (UDI), the gold standard to assess refractory lower urinary tract symptoms (LUTS), is appropriate to select healthy volunteers with apparent normal lower u...

Prevalence of metabolic syndrome and its association with lower urinary tract symptoms and sexual function.

To estimate the frequency of metabolic syndrome (MetS) in a daily urology practice and to determine its association with lower urinary tract symptoms (LUTS) and erectile dysfunction (ED).

Impact of Androgen Deprivation Therapy on Volume Reduction and Lower Urinary Tract Symptoms in Patients with Prostate Cancer.

To evaluate the impact of androgen deprivation therapy (ADT) on prostate volume, lower urinary tract symptoms (LUTS), and LUTS-related quality of life (QOL) in patients with prostate cancer.

Medical and Biotech [MESH] Definitions

Symptoms of disorders of the lower urinary tract including frequency, NOCTURIA; urgency, incomplete voiding, and URINARY INCONTINENCE. They are often associated with OVERACTIVE BLADDER; URINARY INCOMPETENCE; and INTERSTITIAL CYSTITIS. Lower urinary tract symptoms in males were traditionally called PROSTATISM.

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.

More From BioPortfolio on "MCS in the Treatment of Lower Urinary Tract Symptoms"

Quick Search
Advertisement
 

Searches Linking to this Trial