Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00501371
Status:
TERMINATED
Last Update Posted:
2011-12-14
First Post:
2007-07-10
Brief Title:
MCS in Treating Lower Urinary Tract Symptoms LUTS Suggestive of Benign Prostatic Hyperplasia
Sponsor:
Health Ever Bio-Tech Co Ltd
Organization:
Health Ever Bio-Tech Co Ltd
Study Overview
Official Title:
Double-Blind Randomized Placebo-Controlled Study to Investigate the Efficacy and Safety of MCS in Treating Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia
Status:
TERMINATED
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated for re-design A new IND study US FDA July 2009 will be conducted in US and Taiwan Termination not related to safety concerns
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase III Randomized double-blind parallel placebo-controlled study Two arms MCS 30mgday vs placebo
Subproject MCS-2 alpha-blocker naïve subjects
Subproject MCS-3 subjects responding poorly to alpha-blocker
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 N188 after a two-week washout period will be randomized at 11 ratio to receive either MCS 30 mgday or placebo for 12 weeks
Group A MCS 30 mgday 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 N242 after a two-week washout period will be randomized at 11 ratio to receive either MCS 30 mgday plus alpha-blocker or placebo plus alpha-blocker for 12 weeks
Group A alpha-blocker plus MCS 30 mgday 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
Group A MCS 30 mgday 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 N242 after a two-week washout period will be randomized at 11 ratio to receive either MCS 30 mgday plus alpha-blocker or placebo plus alpha-blocker for 12 weeks
Group A alpha-blocker plus MCS 30 mgday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None