MCS in the Treatment of Lower Urinary Tract Symptoms

Last updated: March 1, 2015
Sponsor: Health Ever Bio-Tech Co., Ltd.
Overall Status: Completed

Phase

2/3

Condition

Prostate Disorders

Enuresis

Interstitial Cystitis

Treatment

N/A

Clinical Study ID

NCT01002417
MCS-2-US-a
  • Ages > 40
  • Male

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 274
Study Start date:
July 01, 2010
Estimated Completion Date:
February 28, 2014

Study 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).

Connect with a study center

  • Medical Affiliated Research Center, Inc.

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • South Orange County Medical Research Center

    Laguna Hills, California 92653
    United States

    Site Not Available

  • David Geffen School of Medicine at UCLA

    Los Angeles, California 90095
    United States

    Site Not Available

  • California Professional Research

    Newport Beach, California 92660
    United States

    Site Not Available

  • Medical Center for Clinical Research

    San Diego, California 92108
    United States

    Site Not Available

  • Genitourinary Surgical Consultants

    Denver, Colorado 80220
    United States

    Site Not Available

  • Tampa Bay Medical Research, Inc.

    Clearwater, Florida 33761
    United States

    Site Not Available

  • Mount Vernon Clincial Research, LLC

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • North Idaho Urology

    Ironwood, Idaho 83814
    United States

    Site Not Available

  • Northeast Indiana Research, LLC

    Fort Wayne, Indiana 46825
    United States

    Site Not Available

  • The Iowa Clinic

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • Michigan Institute of Urology, P.C.

    Troy, Michigan 48084
    United States

    Site Not Available

  • Quality Clinical Research , Inc.

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Premier Urology Associates, LLC

    Lawrenceville, New Jersey 08648
    United States

    Site Not Available

  • Premier Medical Center of the Hudson Valley

    Poughkeepsie, New York 12061
    United States

    Site Not Available

  • Center for Urologic Research of WNY, LLC

    Williamsville, New York 14221
    United States

    Site Not Available

  • Northeast Urology Research

    Concord, North Carolina 28025
    United States

    Site Not Available

  • Crescent Medical Research

    Salisburg, North Carolina 28144
    United States

    Site Not Available

  • TriState Urologic Services PSC, Inc. dba TUG Research

    Cincinnati, Ohio 45212
    United States

    Site Not Available

  • Urological Associates of Lancaster

    Lancaster, Pennsylvania 17604-3200
    United States

    Site Not Available

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

  • Salt Lake Research, PLLC

    Salt Lake City, Utah 84107
    United States

    Site Not Available

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