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

October 21, 2009
February 19, 2014
August 2010
December 2014   (final data collection date for primary outcome measure)
Incidence of treatment-emergent adverse events [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
Incidence of treatment-emergent adverse events (TEAE) [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01002274 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Changes from baseline in 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 ]
Not Provided
Not Provided
 
Open-Label Extension Study of MCS-2 in the Treatment of Lower Urinary Tract Symptoms
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

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.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lower Urinary Tract Symptoms
  • Benign Prostatic Hyperplasia
Drug: MCS-2
2 soft-gel capsules Qd for 24 weeks
Other Name: MUS
Experimental: MCS-2
2 soft-gel capsules Qd for 24 weeks
Intervention: Drug: MCS-2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
March 2015
December 2014   (final data collection date for primary outcome measure)

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).
Male
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01002274
MCS-2-TWN-c
No
Health Ever Bio-Tech Co., Ltd.
Health Ever Bio-Tech Co., Ltd.
Not Provided
Principal Investigator: Yeong-Shiau Pu, MD, PhD National Taiwan University Hospital
Health Ever Bio-Tech Co., Ltd.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP