L-O-MÂ® 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 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 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).
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
Lower Urinary Tract Symptoms
L-O-M® MCS 15 mg/day, L-O-M® MCS 30 mg/day, Placebo
David Geffen School of Medicine at UCLA
Not yet recruiting
Health Ever Bio-Tech Co., Ltd.
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT01002417
- Information obtained from ClinicalTrials.gov on July 15, 2010
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.
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...
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...
This is an investigator-initiated study of safety, efficacy and tolerability of dutasteride given for 18 months, including a 1-year double-blind randomized co-administration with either to...
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.
OBJECTIVE. Chronic lower urinary tract symptoms are common in women. We present a classification of abnormalities that can be considered in the differential diagnosis for lower urinary tract symptoms...
Up to 50 % of heart failure patients suffer from lower urinary tract symptoms. Urinary incontinence has been associated with worse functional status in patients with heart failure, occurring three ti...
Involvement of magnitude of ambient temperature change in nonspecific effect in perceived placebo effect on lower urinary tract symptoms: study on switching of naftopidil in patients with benign prostatic hyperplasia.
To determine if switching from one brand of the α1-adrenoceptor antagonist naftopidil (Avishot™) to another brand (Flivas™) under the same conditions causes the same changes in lower urinary trac...
Erectile dysfunction (ED) and lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) are often associated, and they both reduce the quality of life of those who suffer from thes...
To assess the clinical efficiency and safety of combination pharmacotherapy of antimuscarinics and α-blockers vs α-blockers monotherapy on patients with moderate to severe lower urinary tract sympto...