MCS 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:
NCT01002417
First received: October 25, 2009
Last updated: February 20, 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 15 mg/day
Drug: MCS-2 30 mg/day
Drug: Placebo
Phase 2
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: An Adaptive, Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Study to Establish the Dosage, Efficacy, and Safety of MCS-2 in Treating Lower Urinary Tract Symptoms Suggestive of BPH in Treatment-Naive Male Subjects

Resource links provided by NLM:


Further study details as provided by Health Ever Bio-Tech Co., Ltd.:

Primary Outcome Measures:
  • Changes from baseline in International Prostate Symptom Scores [ 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 QOL index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Changes in urine flow rate [ Time Frame: 12 weels ] [ Designated as safety issue: No ]
  • Incidence of treatment-emergent adverse events (TEAE) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of withdrawals due to TEAEs [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 262
Study Start Date: July 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Both the phase 2b and phase 3 parts of the study have the placebo arm.
Drug: Placebo
Two matching placebo soft-gel capsules, oral daily for 12 weeks.
Other Name: MCS matching placebo
Active Comparator: MCS-2 15 mg/day
For the phase 2b part of the study. It can also be used in the phase 3 part of the study if MCS-2 15 mg/day is selected as the optimal dosage.
Drug: MCS-2 15 mg/day
One MCS-2 15 mg soft-gel capsule plus one matching placebo capsule, oral daily for 12 weeks.
Other Name: MUS
Drug: MCS-2 30 mg/day
Two MCS-2 soft-gel capsules, oral daily for 12 weeks.
Other Name: MUS
Active Comparator: MCS-2 30 mg/day
For the phase 2b part of the study. It can also be used in the phase 3 part of the study if MCS-2 30 mg/day is selected as the optimal dosage.
Drug: MCS-2 15 mg/day
One MCS-2 15 mg soft-gel capsule plus one matching placebo capsule, oral daily for 12 weeks.
Other Name: MUS
Drug: MCS-2 30 mg/day
Two MCS-2 soft-gel capsules, oral daily for 12 weeks.
Other Name: MUS

Detailed Description:

This is an adaptive trial design, that combines elements of a Phase 2b (dose ranging) study and a Phase 3 (hypothesis testing) study, the objectives for the two phases are separate.

Phase 2b Objectives: The primary objective of the Phase 2b portion of this study is to evaluate, in a treatment-naïve population, the 0 mg (placebo), 15 mg, and 30 mg MCS-2 in terms of dose response and to determine the optimal dose to be used in the Phase 3 portion of this trial. The secondary objective of this portion of the study is to evaluate the safety and tolerability of the 15 mg and 30 mg MCS-2.

Phase 3 Objectives: The primary objective of the Phase 3 portion of this study is to evaluate, in a treatment-naïve population, the effectiveness of the MCS-2 (at the dosage determined in the Phase 2b portion of this study), as compared to MCS placebo (0 mg), in reducing the lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). The secondary objective of this study is to evaluate the safety and tolerability of MCS-2 (at the dosage determined in the Phase 2b portion of this study), as compared to MCS placebo (0 mg).

  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: NCT01002417

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: NCT01002417     History of Changes
Other Study ID Numbers: MCS-2-US-a
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
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 21, 2014