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
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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.