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Efficacy and Safety of MCS-2 in the Treatment of Lower Urinary Tract Symptoms (MCS_LUTS)

Primary Purpose

Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia

Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
MCS-2
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 Lower Urinary Tract Symptoms focused on measuring Benign Prostatic Hyperplasia, Multi-carotenoids, MCS-2, Lower Urinary Tract Symptoms, International prostate symptom scores

Eligibility Criteria

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

Inclusion Criteria:

  • Age ≧ 40 years old.
  • Not being treated for BPH or LUTS.
  • PSA ≦ 4 ng/ml and no pathologically-proven prostate cancer.
  • I-PSS ≥ 10
  • No known malignancy
  • AST/ALT ≦ 3X UNL.
  • Creatinine ≦ 3X UNL.
  • Subjects who sign the informed consent form.

Exclusion Criteria:

  • Subjects' LUTS are not BPH-related
  • Have been treated with pelvis irradiation or pelvic surgery.
  • Plan to undergo any invasive procedures within the study period.
  • Active infection or inflammation.
  • Considered ineligible by the investigators.

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

MCS-2

Placebo

Arm Description

Drug Name: MCS-2 Dosage: 2 soft-gel capsules Frequency: Qd per day after dinner Duration: 12 weeks

Drug Name: MCS-2 placebo Dosage: 2 soft-gel capsules Frequency: Qd per day after dinner Duration: 12 weeks

Outcomes

Primary Outcome Measures

Changes in total International Prostate Symptom Scores (I-PSS)
Changes in total International Prostate Symptom Scores (I-PSS)

Secondary Outcome Measures

Changes in I-PSS subscores
Changes in I-PSS subscores
Changes in I-PSS quality of life index
Changes in I-PSS quality of life index
Changes in urinary peak flow rate
Changes in urinary peak flow rate
Incidence of treatment-emergent adverse events
Incidence of treatment-emergent adverse events
Incidence of withdrawals due to treatment-emergent adverse events
Incidence of withdrawals due to treatment-emergent adverse events

Full Information

First Posted
October 20, 2009
Last Updated
July 31, 2018
Sponsor
Health Ever Bio-Tech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01002664
Brief Title
Efficacy and Safety of MCS-2 in the Treatment of Lower Urinary Tract Symptoms
Acronym
MCS_LUTS
Official Title
A Phase III, Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of MCS-2 in Treating Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia in Treatment Naïve Male Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (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
The hypothesis of the study is to examine whether MCS-2 is safe and effective in the treatment of lower urinary tract symptoms suggestive of benign prostatic hyperplasia.
Detailed Description
Eligible male subjects will be randomized to receive either MCS-2 or placebo for 12 weeks. Subjects are those not currently on any medicines for BPH or LUTS. During and at the end of the 12-week treatment period, randomized subjects will be evaluated for efficacy and safety parameters. All subjects will be advised to maintain a normal diet, similar to what was consumed before joining the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia
Keywords
Benign Prostatic Hyperplasia, Multi-carotenoids, MCS-2, Lower Urinary Tract Symptoms, International prostate symptom scores

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
MCS-2
Arm Type
Active Comparator
Arm Description
Drug Name: MCS-2 Dosage: 2 soft-gel capsules Frequency: Qd per day after dinner Duration: 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Drug Name: MCS-2 placebo Dosage: 2 soft-gel capsules Frequency: Qd per day after dinner Duration: 12 weeks
Intervention Type
Drug
Intervention Name(s)
MCS-2
Other Intervention Name(s)
MUS
Intervention Description
30 mg/day (two 15 mg capsules) Qd for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
MCS Matching Placebo
Intervention Description
2 soft-gel placebo capsules Qd for 12 weeks
Primary Outcome Measure Information:
Title
Changes in total International Prostate Symptom Scores (I-PSS)
Description
Changes in total International Prostate Symptom Scores (I-PSS)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in I-PSS subscores
Description
Changes in I-PSS subscores
Time Frame
12 weeks
Title
Changes in I-PSS quality of life index
Description
Changes in I-PSS quality of life index
Time Frame
12 weels
Title
Changes in urinary peak flow rate
Description
Changes in urinary peak flow rate
Time Frame
12 weeks
Title
Incidence of treatment-emergent adverse events
Description
Incidence of treatment-emergent adverse events
Time Frame
12 weeks
Title
Incidence of withdrawals due to treatment-emergent adverse events
Description
Incidence of withdrawals due to treatment-emergent adverse events
Time Frame
12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≧ 40 years old. Not being treated for BPH or LUTS. PSA ≦ 4 ng/ml and no pathologically-proven prostate cancer. I-PSS ≥ 10 No known malignancy AST/ALT ≦ 3X UNL. Creatinine ≦ 3X UNL. Subjects who sign the informed consent form. Exclusion Criteria: Subjects' LUTS are not BPH-related Have been treated with pelvis irradiation or pelvic surgery. Plan to undergo any invasive procedures within the study period. 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
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy and Safety of MCS-2 in the Treatment of Lower Urinary Tract Symptoms

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