MCS in the Treatment of Lower Urinary Tract Symptoms (MCS_LUTS)

March 1, 2015 updated by: Health Ever Bio-Tech Co., Ltd.

An Adaptive, Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Study to Establish the Dosage, Efficacy, and Safety of MCS-2 in Treating Lower Urinary Tract Symptoms Suggestive of BPH in Treatment-Naive Male Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

274

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • David Geffen School of Medicine at UCLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Both the phase 2b and phase 3 parts of the study have the placebo arm.
Drug: Placebo
Two matching placebo soft-gel capsules, oral daily for 12 weeks.
Other Names:
  • MCS matching placebo
Active Comparator: 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.
Drug: MCS-2 15 mg/day
One MCS-2 15 mg soft-gel capsule plus one matching placebo capsule, oral daily for 12 weeks.
Other Names:
  • MUS
Drug: MCS-2 30 mg/day
Two MCS-2 soft-gel capsules, oral daily for 12 weeks.
Other Names:
  • MUS
Active Comparator: 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.
Drug: MCS-2 15 mg/day
One MCS-2 15 mg soft-gel capsule plus one matching placebo capsule, oral daily for 12 weeks.
Other Names:
  • MUS
Drug: MCS-2 30 mg/day
Two MCS-2 soft-gel capsules, oral daily for 12 weeks.
Other Names:
  • MUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes from baseline in International Prostate Symptom Scores
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Health Ever Bio-Tech Co., Ltd.

Investigators

  • Principal Investigator: Allan J Pantuck, MD, MS, FACS, University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

October 25, 2009

First Submitted That Met QC Criteria

October 26, 2009

First Posted (Estimate)

October 27, 2009

Study Record Updates

Last Update Posted (Estimate)

March 3, 2015

Last Update Submitted That Met QC Criteria

March 1, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCS-2-US-a

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lower Urinary Tract Symptoms

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe