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
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
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014