Back to resultsOpen-Label Extension Study of MCS-2 in the Treatment of Lower Urinary Tract Symptoms (MCS-2-US-c) (MCS-2-US-c)
Primary Purpose
Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
MCS-2
Sponsored by
About this trial
This is an interventional treatment trial for Lower Urinary Tract Symptoms focused on measuring Benign Prostatic Hyperplasia, MCS-2, Multi-Carotenoids, Lower Urinary Tract Symptoms, International prostate symptom score
Eligibility Criteria
Inclusion Criteria:
- Subject has completed 12 weeks of treatment under the protocol MCS-2-US-a.
- Subject is able to understand and willing to conform to the study procedures and has signed the informed consent form for participation in this extension study.
Exclusion Criteria:
- Subject has severe LUTS at the last visit under the protocol MCS-2-US-a.
- Subject is considered ineligible for the study by the investigator(s).
Sites / Locations
- David Geffen School of Medicine at UCLA
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MCS-2
Arm Description
Outcomes
Primary Outcome Measures
Incidence of treatment-emergent adverse events (TEAE)
Secondary Outcome Measures
Changes from baseline in International Prostate Symptom Score (I-PSS)
Changes from baseline in urine flow rate
Changes from baseline in serum lycopene levels
Full Information
NCT ID
NCT01002222
First Posted
October 25, 2009
Last Updated
March 1, 2015
Sponsor
Health Ever Bio-Tech Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01002222
Brief Title
Open-Label Extension Study of MCS-2 in the Treatment of Lower Urinary Tract Symptoms (MCS-2-US-c)
Acronym
MCS-2-US-c
Official Title
Open-Label, Six-Month Extension of Protocol MCS-2-TWN-a to Further Evaluate the Efficacy and Safety of MCS-2 for the Treatment of Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia in Treatment Naïve Male Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (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
This is an open-label extension study of another study protocol, MCS-2-US-a. Subjects who have completed the 12-week treatment and procedures under the protocol MCS-2-US-a will be eligible for this study.
Detailed Description
This open-label extension study is designed to further assess the long-term safety and efficacy of MCS-2. Subjects who have completed the 12-week treatment and procedures under the protocol MCS-2-TWN-a will be eligible for another 40 weeks of MCS-2 treatment at the optimal dose selected after the phase 2b part of MCS-2-US-a. Subjects are limited to those who are currently not being treated medically for BPH or LUTS.
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, MCS-2, Multi-Carotenoids, Lower Urinary Tract Symptoms, International prostate symptom score
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MCS-2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MCS-2
Other Intervention Name(s)
MUS
Intervention Description
15 or 30 mg/day of MCS-2 soft-gel capsules Qd for 24 weeks, depending on which dose level is selected after the phase 2b part of the protocol MCS-2-US-a.
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events (TEAE)
Time Frame
36 weeks
Secondary Outcome Measure Information:
Title
Changes from baseline in International Prostate Symptom Score (I-PSS)
Time Frame
36 weeks
Title
Changes from baseline in urine flow rate
Time Frame
36 weeks
Title
Changes from baseline in serum lycopene levels
Time Frame
36 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject has completed 12 weeks of treatment under the protocol MCS-2-US-a.
Subject is able to understand and willing to conform to the study procedures and has signed the informed consent form for participation in this extension study.
Exclusion Criteria:
Subject has severe LUTS at the last visit under the protocol MCS-2-US-a.
Subject is considered ineligible for the study by the investigator(s).
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
Open-Label Extension Study of MCS-2 in the Treatment of Lower Urinary Tract Symptoms (MCS-2-US-c)
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