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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Health Ever Bio-Tech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01002222
First received: October 25, 2009
Last updated: February 20, 2014
Last verified: September 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes from baseline in International Prostate Symptom Score (I-PSS) [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in urine flow rate [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in serum lycopene levels [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 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

Ages Eligible for Study:   40 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Health Ever Bio-Tech Co., Ltd.
ClinicalTrials.gov Identifier: NCT01002222     History of Changes
Other Study ID Numbers: MCS-2-US-c
Study First Received: October 25, 2009
Last Updated: February 20, 2014
Health Authority: United States: Food and Drug Administration

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:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014