NCT00501371

Brief Summary

Phase III, Randomized, double-blind, parallel placebo-controlled study. Two arms: MCS (30mg/day) vs. placebo. Subproject MCS-2: alpha-blocker naïve subjects Subproject MCS-3: subjects responding poorly to alpha-blocker

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2007

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 16, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

December 14, 2011

Status Verified

December 1, 2011

Enrollment Period

2.3 years

First QC Date

July 10, 2007

Last Update Submit

December 13, 2011

Conditions

Benign Prostatic Hyperplasia

Keywords

Benign Prostatic HyperplasiaMCSLower Urinary Tract SymptomsInternational prostate symptom scoreVoidingAlpha-blockers

Outcome Measures

Primary Outcomes (2)

  • MCS-2: To compare changes in I-PSS points after 12 weeks of MCS or placebo supplementation.

    12 weeks

  • MCS-3: To compare the percentage of subjects who achieve an I-PSS reduction by 4 or more points from baseline at 12 weeks between the MCS and the placebo arms.

    12 weeks

Secondary Outcomes (1)

  • To evaluate the general safety and tolerability.

    12 weeks

Study Arms (2)

MCS

ACTIVE COMPARATOR

Group A: MCS 30 mg/day for 12 weeks

Drug: MCS

Placebo

PLACEBO COMPARATOR

Placebo, 2 capsules per day

Drug: Placebo

Interventions

MCSDRUG

soft-gel capsule, 15 mg/cap., Qd, 12 weeks

Also known as: MUS
MCS
PlaceboDRUG

soft-gel capsule, Qd, 12 weeks

Also known as: MUS
Placebo

Eligibility Criteria

Age40 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≧ 40 years old.
  • Not being treated for BPH or LUTS with Alpha-blocker, anti-cholinergics, 5-alpha reductase inhibitors, or hormonal agents.
  • PSA≦4 ng/ml within 4 weeks of V1 and no pathologically-proven prostate cancer.
  • No known malignancy, except cancers without signs of recurrence for \> 5 years and no need for further anti-cancer treatment.
  • AST/ALT≦3X UNL.
  • creatinine≦3X UNL.
  • Subjects who sign the informed consent form.

You may not qualify if:

  • Subjects' LUTS are not BPH-related but are associated with such conditions as urethral stricture, prostatitis, neurogenic bladder, or pelvic treatment procedures.
  • Have been treated with pelvis irradiation or pelvic surgery.
  • Plan to undergo any invasive procedures within the study period, such as, prostate surgery, prostate biopsy, cystourethroscopy, pelvic surgery, laparotomy, or any procedures needing urethral catheterization.
  • Participating in another investigational agent study in the past 12 weeks or are going to do so during the study period.
  • Active infection or inflammation.
  • Considered ineligible by the investigators.
  • Age≧40 years old.
  • The alpha-blocker dosage used should be as high as subjects can tolerate.
  • No known malignancy, except cancers without signs of recurrence for \> 5 years and no need for further anti-cancer treatment.
  • PSA≦10.0 ng/ml without pathologically-proven prostate cancer or other cancers. Prostate biopsy is mandatory \> 12 weeks before screening, if PSA is≧4 ng/ml to rule out prostate cancer.
  • AST/ALT≦3X UNL.
  • Creatinine≦3X UNL.
  • Subjects who sign the informed consent form.
  • Subjects' LUTS are not BPH-related but associated with such conditions as urethral stricture, prostatitis, neurogenic bladder, or pelvic treatment procedures.
  • Subjects who have been treated with pelvis irradiation or pelvic surgery.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Chang Gung Memorial Hospital

Chiayi City, 613, Taiwan

Location

Chung-Ho Memorial Hospital,Kaohsiung Medical University

Kaohsiung City, 807, Taiwan

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, 807, Taiwan

Location

China Medical University Hospital

Taichung, 404, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Prostatic HyperplasiaLower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yeong-Shiau Pu, MD, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2007

First Posted

July 16, 2007

Study Start

July 1, 2007

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

December 14, 2011

Record last verified: 2011-12

Locations

TW(5)