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

Benign Prostatic Hyperplasia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01002222
• Other study ID #: MCS-2-US-c
• Status: Completed
• Phase: Phase 3
• First received: October 25, 2009
• Last updated: March 1, 2015
• Start date: January 2011
• Est. completion date: February 2014

Study information

• Verified date: March 2015
• Source: Health Ever Bio-Tech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Drug:
• MCS-2
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.

Locations

Country	Name	City	State
United States	David Geffen School of Medicine at UCLA	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Health Ever Bio-Tech Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events (TEAE)		36 weeks	Yes
Secondary	Changes from baseline in International Prostate Symptom Score (I-PSS)		36 weeks	No
Secondary	Changes from baseline in urine flow rate		36 weeks	No
Secondary	Changes from baseline in serum lycopene levels		36 weeks	No