MCS in Treating Lower Urinary Tract Symptoms (LUTS) Suggestive of Benign Prostatic Hyperplasia
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|ClinicalTrials.gov Identifier: NCT00501371|
Recruitment Status : Terminated (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.)
First Posted : July 16, 2007
Last Update Posted : December 14, 2011
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
|Condition or disease||Intervention/treatment||Phase|
|Benign Prostatic Hyperplasia||Drug: MCS Drug: Placebo||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
Active Comparator: MCS
Group A: MCS 30 mg/day for 12 weeks
soft-gel capsule, 15 mg/cap., Qd, 12 weeks
Other Name: MUS
Placebo Comparator: Placebo
Placebo, 2 capsules per day
soft-gel capsule, Qd, 12 weeks
Other Name: MUS
- MCS-2: To compare changes in I-PSS points after 12 weeks of MCS or placebo supplementation. [ Time Frame: 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. [ Time Frame: 12 weeks ]
- To evaluate the general safety and tolerability. [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00501371
|Chang Gung Memorial Hospital|
|Chiayi, Taiwan, 613|
|Chung-Ho Memorial Hospital,Kaohsiung Medical University|
|Kaohsiung, Taiwan, 807|
|Kaohsiung Veterans General Hospital|
|Kaohsiung, Taiwan, 807|
|China Medical University Hospital|
|Taichung, Taiwan, 404|
|National Taiwan University Hospital|
|Taipei, Taiwan, 100|
|Principal Investigator:||Yeong-Shiau Pu, MD, PhD||National Taiwan University Hospital|