MCS in Treating Lower Urinary Tract Symptoms (LUTS) Suggestive of Benign Prostatic Hyperplasia

Phase 3

Terminated

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Drug: MCS; Drug: Placebo

• Registration Number: NCT00501371
• Lead Sponsor: Health Ever Bio-Tech Co., Ltd.

Brief Summary

Phase III, Randomized, double-blind, parallel placebo-controlled study. Two arms: MCS (30mg/day) vs. placebo.

Subproject MCS-2: alpha-blocker naïve subjects

Subproject MCS-3: subjects responding poorly to alpha-blocker

Detailed Description

For MCS-2 This is a double-blind, randomized, placebo-controlled, parallel study where eligible male subjects (age 40, N=188), after a two-week washout period, will be randomized at 1:1 ratio to receive either MCS 30 mg/day or placebo for 12 weeks.

Group A: MCS 30 mg/day for 12 weeks Group B: placebo for 12 weeks

Subjects are limited to those who are currently not being treated medically for BPH or LUTS with alpha-blockers, anti-cholinergics, 5-alpha reductase inhibitors, or hormonal therapeutic agents. For each treatment arm, about 85 subjects eligible for final per protocol analysis will be recruited. Concerning an expected dropout rate of 10%, 188 subjects in total will be recruited onto the study.

For MCS-3 This is a double-blind, randomized, placebo-controlled, add-on, parallel study where eligible male subjects (age 40, N=242), after a two-week washout period, will be randomized at 1:1 ratio to receive either MCS 30 mg/day plus alpha-blocker or placebo plus alpha-blocker for 12 weeks.

Group A: alpha-blocker plus MCS 30 mg/day Group B: alpha-blocker plus placebo

Subjects are limited to those who are currently not being treated medically for BPH or LUTS with anti-cholinergics, 5-alpha reductase inhibitors, or hormonal therapeutic agents. For each treatment arm, about 220 subjects eligible for final per protocol analysis will be recruited. Concerning an expected dropout rate of 10%, 242 subjects in total will be recruited onto the study.

All participating subjects will be advised to maintain a normal diet as they do before joining the study. However, participating subjects are advised to refrain from extra source of carotenoids supplementation and MCS extracts made into a capsule, soft gel, or crude granule extracts.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-10
• Study First Submitted QC: 2007-07-12
• Study First Posted: 2007-07-16
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-13
• Last Update Posted: 2011-12-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 85

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MCS	MCS	Group A: MCS 30 mg/day for 12 weeks
Placebo	Placebo	Placebo, 2 capsules per day

Primary Outcome Measures

Name	Time	Method
MCS-2: To compare changes in I-PSS points after 12 weeks of MCS or placebo supplementation.	12 weeks
MCS-3: To compare the percentage of subjects who achieve an I-PSS reduction by 4 or more points from baseline at 12 weeks between the MCS and the placebo arms.	12 weeks

Secondary Outcome Measures

Name	Time	Method
To evaluate the general safety and tolerability.	12 weeks

Trial Locations

Locations (5)

Chang Gung Memorial Hospital; 🇨🇳 Chiayi, Taiwan

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan

Chung-Ho Memorial Hospital,Kaohsiung Medical University; 🇨🇳 Kaohsiung, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

China Medical University Hospital; 🇨🇳 Taichung, Taiwan