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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Health Ever Bio-Tech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01002274
First received: October 21, 2009
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

This is an open-label extension study of another study protocol, MCS-2-TWN-a. Subjects who have completed the 12-week treatment and procedures under the protocol MCS-2-TWN-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 [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes from baseline in International Prostate Symptom Scores (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 ]

Estimated Enrollment: 200
Study Start Date: August 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MCS-2
2 soft-gel capsules Qd for 24 weeks
Drug: MCS-2
2 soft-gel capsules Qd for 24 weeks
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 same daily dosage as the active treatment given under the protocol MCS-2-TWN-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-TWN-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-TWN-a.
  • Subject is considered ineligible for the study by the investigator(s).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01002274

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
Health Ever Bio-Tech Co., Ltd.
Investigators
Principal Investigator: Yeong-Shiau Pu, MD, PhD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Health Ever Bio-Tech Co., Ltd.
ClinicalTrials.gov Identifier: NCT01002274     History of Changes
Other Study ID Numbers: MCS-2-TWN-c
Study First Received: October 21, 2009
Last Updated: February 19, 2014
Health Authority: United States: Food and Drug Administration
Taiwan: Department of Health

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

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

ClinicalTrials.gov processed this record on November 27, 2014