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

Health Ever Bio-Tech

Status and phase: Completed; Phase 3

Conditions: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia

Treatments: Drug: MCS-2

Study type: Interventional

Funder types: Industry

Identifiers

NCT01002222

MCS-2-US-c

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

MCS-2

Experimental group

Treatment:

Drug: MCS-2