Back to resultsOpen-Label Extension Study of MCS-2 in the Treatment of Lower Urinary Tract Symptoms (MCS-2-TWN-c)
Primary Purpose
Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia
Status
Completed
Phase
Phase 3
Locations
Taiwan
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, BPH, 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-TWN-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-TWN-a.
- Subject is considered ineligible for the study by the investigator(s).
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MCS-2
Arm Description
2 soft-gel capsules Qd for 40 weeks
Outcomes
Primary Outcome Measures
Incidence of treatment-emergent adverse events
Secondary Outcome Measures
Changes from baseline in International Prostate Symptom Scores (I-PSS)
Full Information
NCT ID
NCT01002274
First Posted
October 21, 2009
Last Updated
November 10, 2016
Sponsor
Health Ever Bio-Tech Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01002274
Brief Title
Open-Label Extension Study of MCS-2 in the Treatment of Lower Urinary Tract Symptoms
Acronym
MCS-2-TWN-c
Official Title
Open-Label, 40-weeks 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
November 2016
Overall Recruitment Status
Completed
Study Start Date
August 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
This is an open-label extension study of another study protocol, MCS-2-TWN-a. Subjects who have completed the 12-week treatment and procedures under the protocol MCS-2-TWN-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 same daily dosage as the active treatment given under the protocol MCS-2-TWN-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, BPH, 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
N/A
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MCS-2
Arm Type
Experimental
Arm Description
2 soft-gel capsules Qd for 40 weeks
Intervention Type
Drug
Intervention Name(s)
MCS-2
Other Intervention Name(s)
MUS
Intervention Description
2 soft-gel capsules Qd for 40 weeks
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events
Time Frame
40 weeks
Secondary Outcome Measure Information:
Title
Changes from baseline in International Prostate Symptom Scores (I-PSS)
Time Frame
40 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-TWN-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-TWN-a.
Subject is considered ineligible for the study by the investigator(s).
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
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Open-Label Extension Study of MCS-2 in the Treatment of Lower Urinary Tract Symptoms
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