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

Benign Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00501371
• Other study ID #: MCS for BPH-LUTS
• Status: Terminated
• Phase: Phase 3
• First received: July 10, 2007
• Last updated: December 13, 2011
• Start date: July 2007
• Est. completion date: October 2009

Study information

• Verified date: December 2011
• Source: Health Ever Bio-Tech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 85
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

Inclusion criteria for subproject MCS-2

• Age ? 40 years old.

• Not being treated for BPH or LUTS with Alpha-blocker, anti-cholinergics, 5-alpha reductase inhibitors, or hormonal agents.

• PSA?4 ng/ml within 4 weeks of V1 and no pathologically-proven prostate cancer.

• No known malignancy, except cancers without signs of recurrence for > 5 years and no need for further anti-cancer treatment.

• AST/ALT?3X UNL.

• creatinine?3X UNL.

• Subjects who sign the informed consent form.

Exclusion criteria

• Subjects' LUTS are not BPH-related but are associated with such conditions as urethral stricture, prostatitis, neurogenic bladder, or pelvic treatment procedures.

• Have been treated with pelvis irradiation or pelvic surgery.

• Plan to undergo any invasive procedures within the study period, such as, prostate surgery, prostate biopsy, cystourethroscopy, pelvic surgery, laparotomy, or any procedures needing urethral catheterization.

• Participating in another investigational agent study in the past 12 weeks or are going to do so during the study period.

• Active infection or inflammation.

• Considered ineligible by the investigators.

Inclusion criteria for subproject MCS-3

• Age?40 years old.

• The alpha-blocker dosage used should be as high as subjects can tolerate.

• No known malignancy, except cancers without signs of recurrence for > 5 years and no need for further anti-cancer treatment.

• PSA?10.0 ng/ml without pathologically-proven prostate cancer or other cancers. Prostate biopsy is mandatory > 12 weeks before screening, if PSA is?4 ng/ml to rule out prostate cancer.

• AST/ALT?3X UNL.

• Creatinine?3X UNL.

• Subjects who sign the informed consent form.

Exclusion criteria

• Subjects' LUTS are not BPH-related but associated with such conditions as urethral stricture, prostatitis, neurogenic bladder, or pelvic treatment procedures.

• Subjects who have been treated with pelvis irradiation or pelvic surgery.

• PSA > 10.0 ng/ml, abnormal DRE of the prostate or any suspicion of prostate malignancy. However, those who have a negative prostate biopsy are allowed.

• Active infection or inflammation.

• Considered ineligible by the investigators.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Drug:
• MCS
soft-gel capsule, 15 mg/cap., Qd, 12 weeks
• Placebo
soft-gel capsule, Qd, 12 weeks

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Chiayi
Taiwan	Chung-Ho Memorial Hospital,Kaohsiung Medical University	Kaohsiung
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Health Ever Bio-Tech Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MCS-2: To compare changes in I-PSS points after 12 weeks of MCS or placebo supplementation.		12 weeks	No
Primary	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	No
Secondary	To evaluate the general safety and tolerability.		12 weeks	Yes