MCS in the Treatment of Lower Urinary Tract Symptoms

Phase 2

Completed

• Conditions: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia
• Interventions: Drug: MCS-2 15 mg/day; Drug: Placebo; Drug: MCS-2 30 mg/day

• Registration Number: NCT01002417
• Lead Sponsor: Health Ever Bio-Tech Co., Ltd.

Brief Summary

The hypothesis of the study is to examine whether MCS-2 is safe and effective in the treatment of lower urinary tract symptoms suggestive of benign prostatic hyperplasia.

Detailed Description

This is an adaptive trial design, that combines elements of a Phase 2b (dose ranging) study and a Phase 3 (hypothesis testing) study, the objectives for the two phases are separate.

Phase 2b Objectives: The primary objective of the Phase 2b portion of this study is to evaluate, in a treatment-naïve population, the 0 mg (placebo), 15 mg, and 30 mg MCS-2 in terms of dose response and to determine the optimal dose to be used in the Phase 3 portion of this trial. The secondary objective of this portion of the study is to evaluate the safety and tolerability of the 15 mg and 30 mg MCS-2.

Phase 3 Objectives: The primary objective of the Phase 3 portion of this study is to evaluate, in a treatment-naïve population, the effectiveness of the MCS-2 (at the dosage determined in the Phase 2b portion of this study), as compared to MCS placebo (0 mg), in reducing the lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). The secondary objective of this study is to evaluate the safety and tolerability of MCS-2 (at the dosage determined in the Phase 2b portion of this study), as compared to MCS placebo (0 mg).

Study Timeline

• Study First Submitted: 2009-10-25
• Study First Submitted QC: 2009-10-26
• Study First Posted: 2009-10-27
• Study Start: 2010-07
• 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: 274

Inclusion Criteria

• Age ≧ 40 years old
• Not being treated for BPH or LUTS
• PSA ≦ 4 ng/ml and no pathologically-proven prostate cancer
• I-PSS ≥ 10
• No known malignancy
• AST/ALT ≦ 3X UNL
• Creatinine ≦ 3X UNL
• Subjects who sign the informed consent form

Exclusion Criteria

• Subjects' LUTS are not BPH-related
• Have been treated with pelvis irradiation or pelvic surgery
• Plan to undergo any invasive procedures within the study period
• Active infection or inflammation
• Considered ineligible by the investigators

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MCS-2 15 mg/day	MCS-2 15 mg/day	For the phase 2b part of the study. It can also be used in the phase 3 part of the study if MCS-2 15 mg/day is selected as the optimal dosage.
MCS-2 30 mg/day	MCS-2 30 mg/day	For the phase 2b part of the study. It can also be used in the phase 3 part of the study if MCS-2 30 mg/day is selected as the optimal dosage.
MCS-2 15 mg/day	MCS-2 30 mg/day	For the phase 2b part of the study. It can also be used in the phase 3 part of the study if MCS-2 15 mg/day is selected as the optimal dosage.
MCS-2 30 mg/day	MCS-2 15 mg/day	For the phase 2b part of the study. It can also be used in the phase 3 part of the study if MCS-2 30 mg/day is selected as the optimal dosage.
Placebo	Placebo	Both the phase 2b and phase 3 parts of the study have the placebo arm.

Primary Outcome Measures

Name	Time	Method
Changes from baseline in International Prostate Symptom Scores	12 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in I-PSS subscores	12 weeks
Changes in I-PSS QOL index	12 weeks
Changes in urine flow rate	12 weels
Incidence of treatment-emergent adverse events (TEAE)	12 weeks
Incidence of withdrawals due to TEAEs	12 weeks

Trial Locations

Locations (1)

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