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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01002222
First Posted: October 27, 2009
Last Update Posted: March 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Health Ever Bio-Tech Co., Ltd.
  Purpose
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.

Condition Intervention Phase
Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia Drug: MCS-2 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label, Six-Month 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

Resource links provided by NLM:


Further study details as provided by Health Ever Bio-Tech Co., Ltd.:

Primary Outcome Measures:
  • Incidence of treatment-emergent adverse events (TEAE) [ Time Frame: 36 weeks ]

Secondary Outcome Measures:
  • Changes from baseline in International Prostate Symptom Score (I-PSS) [ Time Frame: 36 weeks ]
  • Changes from baseline in urine flow rate [ Time Frame: 36 weeks ]
  • Changes from baseline in serum lycopene levels [ Time Frame: 36 weeks ]

Estimated Enrollment: 200
Study Start Date: January 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MCS-2 Drug: MCS-2
15 or 30 mg/day of MCS-2 soft-gel capsules Qd for 24 weeks, depending on which dose level is selected after the phase 2b part of the protocol MCS-2-US-a.
Other Name: MUS

Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01002222


Locations
United States, California
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Health Ever Bio-Tech Co., Ltd.
Investigators
Principal Investigator: Allan J Pantuck, MD, MS, FACS University of California, Los Angeles
  More Information

Responsible Party: Health Ever Bio-Tech Co., Ltd.
ClinicalTrials.gov Identifier: NCT01002222     History of Changes
Other Study ID Numbers: MCS-2-US-c
First Submitted: October 25, 2009
First Posted: October 27, 2009
Last Update Posted: March 3, 2015
Last Verified: March 2015

Keywords provided by Health Ever Bio-Tech Co., Ltd.:
Benign Prostatic Hyperplasia
MCS-2
Multi-Carotenoids
Lower Urinary Tract Symptoms
International prostate symptom score

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Urological Manifestations
Signs and Symptoms