Open-Label Extension Study of MCS-2 in the Treatment of Lower Urinary Tract Symptoms

Benign Prostatic Hyperplasia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01002274
• Other study ID #: MCS-2-TWN-c
• Status: Completed
• Phase: Phase 3
• First received: October 21, 2009
• Last updated: November 10, 2016
• Start date: August 2010
• Est. completion date: June 2014

Study information

• Verified date: November 2016
• Source: Health Ever Bio-Tech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationTaiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: June 2014
• Est. primary completion date: June 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-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).

Study Design

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
2 soft-gel capsules Qd for 40 weeks

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

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

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events		40 weeks	Yes
Secondary	Changes from baseline in International Prostate Symptom Scores (I-PSS)		40 weeks	No