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

Primary Purpose

Benign Prostatic Hyperplasia

Status
Terminated
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
MCS
Placebo
Sponsored by
Health Ever Bio-Tech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Benign Prostatic Hyperplasia, MCS, Lower Urinary Tract Symptoms, International prostate symptom score, Voiding, Alpha-blockers

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Chang Gung Memorial Hospital
  • Chung-Ho Memorial Hospital,Kaohsiung Medical University
  • Kaohsiung Veterans General Hospital
  • China Medical University Hospital
  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

MCS

Placebo

Arm Description

Group A: MCS 30 mg/day for 12 weeks

Placebo, 2 capsules per day

Outcomes

Primary Outcome Measures

MCS-2: To compare changes in I-PSS points after 12 weeks of MCS or placebo supplementation.
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.

Secondary Outcome Measures

To evaluate the general safety and tolerability.

Full Information

First Posted
July 10, 2007
Last Updated
December 13, 2011
Sponsor
Health Ever Bio-Tech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00501371
Brief Title
MCS in Treating Lower Urinary Tract Symptoms (LUTS) Suggestive of Benign Prostatic Hyperplasia
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 Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Terminated
Why Stopped
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.
Study Start Date
July 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Health Ever Bio-Tech Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
Benign Prostatic Hyperplasia, MCS, Lower Urinary Tract Symptoms, International prostate symptom score, Voiding, Alpha-blockers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MCS
Arm Type
Active Comparator
Arm Description
Group A: MCS 30 mg/day for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, 2 capsules per day
Intervention Type
Drug
Intervention Name(s)
MCS
Other Intervention Name(s)
MUS
Intervention Description
soft-gel capsule, 15 mg/cap., Qd, 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
MUS
Intervention Description
soft-gel capsule, Qd, 12 weeks
Primary Outcome Measure Information:
Title
MCS-2: To compare changes in I-PSS points after 12 weeks of MCS or placebo supplementation.
Time Frame
12 weeks
Title
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
Secondary Outcome Measure Information:
Title
To evaluate the general safety and tolerability.
Time Frame
12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yeong-Shiau Pu, MD, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Chiayi
ZIP/Postal Code
613
Country
Taiwan
Facility Name
Chung-Ho Memorial Hospital,Kaohsiung Medical University
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

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

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