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MCS in the Treatment of Lower Urinary Tract Symptoms (MCS_LUTS)

Primary Purpose

Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MCS-2 15 mg/day
MCS-2 30 mg/day
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

  • David Geffen School of Medicine at UCLA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

MCS-2 15 mg/day

MCS-2 30 mg/day

Arm Description

Both the phase 2b and phase 3 parts of the study have the placebo arm.

For the phase 2b part of the study. It can also be used in the phase 3 part of the study if MCS-2 15 mg/day is selected as the optimal dosage.

For the phase 2b part of the study. It can also be used in the phase 3 part of the study if MCS-2 30 mg/day is selected as the optimal dosage.

Outcomes

Primary Outcome Measures

Changes from baseline in International Prostate Symptom Scores

Secondary Outcome Measures

Changes in I-PSS subscores
Changes in I-PSS QOL index
Changes in urine flow rate
Incidence of treatment-emergent adverse events (TEAE)
Incidence of withdrawals due to TEAEs

Full Information

First Posted
October 25, 2009
Last Updated
March 1, 2015
Sponsor
Health Ever Bio-Tech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01002417
Brief Title
MCS in the Treatment of Lower Urinary Tract Symptoms
Acronym
MCS_LUTS
Official Title
An Adaptive, Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Study to Establish the Dosage, Efficacy, and Safety of MCS-2 in Treating Lower Urinary Tract Symptoms Suggestive of BPH in Treatment-Naive Male Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 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
This is an adaptive trial design, that combines elements of a Phase 2b (dose ranging) study and a Phase 3 (hypothesis testing) study, the objectives for the two phases are separate. Phase 2b Objectives: The primary objective of the Phase 2b portion of this study is to evaluate, in a treatment-naïve population, the 0 mg (placebo), 15 mg, and 30 mg MCS-2 in terms of dose response and to determine the optimal dose to be used in the Phase 3 portion of this trial. The secondary objective of this portion of the study is to evaluate the safety and tolerability of the 15 mg and 30 mg MCS-2. Phase 3 Objectives: The primary objective of the Phase 3 portion of this study is to evaluate, in a treatment-naïve population, the effectiveness of the MCS-2 (at the dosage determined in the Phase 2b portion of this study), as compared to MCS placebo (0 mg), in reducing the lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). The secondary objective of this study is to evaluate the safety and tolerability of MCS-2 (at the dosage determined in the Phase 2b portion of this study), as compared to MCS placebo (0 mg).

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 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
274 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Both the phase 2b and phase 3 parts of the study have the placebo arm.
Arm Title
MCS-2 15 mg/day
Arm Type
Active Comparator
Arm Description
For the phase 2b part of the study. It can also be used in the phase 3 part of the study if MCS-2 15 mg/day is selected as the optimal dosage.
Arm Title
MCS-2 30 mg/day
Arm Type
Active Comparator
Arm Description
For the phase 2b part of the study. It can also be used in the phase 3 part of the study if MCS-2 30 mg/day is selected as the optimal dosage.
Intervention Type
Drug
Intervention Name(s)
MCS-2 15 mg/day
Other Intervention Name(s)
MUS
Intervention Description
One MCS-2 15 mg soft-gel capsule plus one matching placebo capsule, oral daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
MCS-2 30 mg/day
Other Intervention Name(s)
MUS
Intervention Description
Two MCS-2 soft-gel capsules, oral daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
MCS matching placebo
Intervention Description
Two matching placebo soft-gel capsules, oral daily for 12 weeks.
Primary Outcome Measure Information:
Title
Changes from baseline in International Prostate Symptom Scores
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in I-PSS subscores
Time Frame
12 weeks
Title
Changes in I-PSS QOL index
Time Frame
12 weeks
Title
Changes in urine flow rate
Time Frame
12 weels
Title
Incidence of treatment-emergent adverse events (TEAE)
Time Frame
12 weeks
Title
Incidence of withdrawals due to TEAEs
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
Allan J Pantuck, MD, MS, FACS
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
David Geffen School of Medicine at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Learn more about this trial

MCS in the Treatment of Lower Urinary Tract Symptoms

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