Efficacy and Safety of MCS-2 in the Treatment of Lower Urinary Tract Symptoms (MCS_LUTS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Health Ever Bio-Tech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01002664
First received: October 20, 2009
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of MCS-2 in Treating 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:
  • Changes in total International Prostate Symptom Scores (I-PSS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in I-PSS subscores [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Changes in I-PSS quality of life index [ Time Frame: 12 weels ] [ Designated as safety issue: No ]
  • Changes in urinary peak flow rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Incidence of treatment-emergent adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of withdrawals due to treatment-emergent adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 267
Study Start Date: May 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MCS-2
Drug Name: MCS-2 Dosage: 2 soft-gel capsules Frequency: Qd per day after dinner Duration: 12 weeks
Drug: MCS-2
30 mg/day (two 15 mg capsules) Qd for 12 weeks
Other Name: MUS
Placebo Comparator: Placebo
Drug Name: MCS-2 placebo Dosage: 2 soft-gel capsules Frequency: Qd per day after dinner Duration: 12 weeks
Drug: Placebo
2 soft-gel placebo capsules Qd for 12 weeks
Other Name: MCS Matching Placebo

Detailed Description:

Eligible male subjects will be randomized to receive either MCS-2 or placebo for 12 weeks. Subjects are those not currently on any medicines for BPH or LUTS. During and at the end of the 12-week treatment period, randomized subjects will be evaluated for efficacy and safety parameters. All subjects will be advised to maintain a normal diet, similar to what was consumed before joining the study.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01002664

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 10002
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: NCT01002664     History of Changes
Other Study ID Numbers: MCS-2-TWN-a
Study First Received: October 20, 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
Multi-carotenoids
MCS-2
Lower Urinary Tract Symptoms
International prostate symptom scores

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

ClinicalTrials.gov processed this record on August 20, 2014