L-O-M® MCS in the Treatment of Lower Urinary Tract Symptoms
Summary
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 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 L-O-M® MCS 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 L-O-M® MCS.
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 L-O-M® MCS (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 L-O-M® MCS (at the dosage determined in the Phase 2b portion of this study), as compared to MCS placebo (0 mg).
Study Design
Allocation: Randomized, Control: Placebo Control, 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
L-O-M® MCS 15 mg/day, L-O-M® MCS 30 mg/day, Placebo
Location
David Geffen School of Medicine at UCLA
Los Angeles
California
United States
90095
Status
Not yet recruiting
Source
Health Ever Bio-Tech Co., Ltd.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01002417
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Prostatism
Lower urinary tract symptom, such as slow urinary stream, associated with PROSTATIC HYPERPLASIA in older men.
Urology
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.
Dysuria
Painful URINATION. It is often associated with infections of the lower URINARY TRACT.
Cefonicid
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.
Urinary Tract Physiological Phenomena
Properties, functions, and processes of the URINARY TRACT as a whole or of any of its parts.
Clinical Trials
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...
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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...
This study will examine the safety, tolerability, and efficacy of YM178 compared to placebo.
PubMed Articles
Benign prostatic hyperplasia and lower urinary tract symptoms.
To the Editor: In their Clinical Practice article (July 19 issue)(1) reviewing therapeutic options for the management of lower urinary tract symptoms, Sarma and Wei refer to European Association of Ur...
Benign prostatic hyperplasia and lower urinary tract symptoms.
To the Editor: In their Clinical Practice article (July 19 issue)(1) reviewing therapeutic options for the management of lower urinary tract symptoms, Sarma and Wei refer to European Association of Ur...
Biomarkers for lower urinary tract dysfunction.
Lower urinary tract dysfunction is highly prevalent, but has relatively low persistence and compliance with therapy because of poor efficacy. Although urodynamic study is the gold standard for detaile...
Gene therapy for lower urinary tract dysfunction.
Lower urinary tract dysfunction is caused by functional and pathophysiological alterations of the peripheral organs, including the urothelium and detrusor smooth muscle, as well as peripheral and cent...
PURPOSE: Lower urinary tract symptoms are common in pediatric patients. To our knowledge no validated instruments properly designed to screen lower urinary tract symptoms in the pediatric population h...
