Open-Label Extension Study of MCS-2 in the Treatment of Lower Urinary Tract Symptoms (MCS-2-US-c)

Phase 3

Completed

• Conditions: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia
• Interventions: Drug: MCS-2

• Registration Number: NCT01002222
• Lead Sponsor: Health Ever Bio-Tech Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2009-10-25
• Study First Submitted QC: 2009-10-26
• Study First Posted: 2009-10-27
• Study Start: 2011-01
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-01
• Last Update Posted: 2015-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 200

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MCS-2	MCS-2	-

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events (TEAE)	36 weeks

Secondary Outcome Measures

Name	Time	Method
Changes from baseline in International Prostate Symptom Score (I-PSS)	36 weeks
Changes from baseline in urine flow rate	36 weeks
Changes from baseline in serum lycopene levels	36 weeks

Trial Locations

Locations (1)

David Geffen School of Medicine at UCLA; 🇺🇸 Los Angeles, California, United States