MCS in Treating Lower Urinary Tract Symptoms (LUTS) Suggestive of Benign Prostatic Hyperplasia

This study has been terminated.
(Study terminated for re-design. A new IND study (US FDA, July 2009) will be conducted in US and Taiwan. Termination not related to safety concerns.)
Sponsor:
Information provided by (Responsible Party):
Health Ever Bio-Tech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00501371
First received: July 10, 2007
Last updated: December 13, 2011
Last verified: December 2011
  Purpose

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


Condition Intervention Phase
Benign Prostatic Hyperplasia
Drug: MCS
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: Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of MCS in Treating Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • MCS-2: To compare changes in I-PSS points after 12 weeks of MCS or placebo supplementation. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the general safety and tolerability. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 85
Study Start Date: July 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MCS
Group A: MCS 30 mg/day for 12 weeks
Drug: MCS
soft-gel capsule, 15 mg/cap., Qd, 12 weeks
Other Name: MUS
Placebo Comparator: Placebo
Placebo, 2 capsules per day
Drug: Placebo
soft-gel capsule, Qd, 12 weeks
Other Name: MUS

Detailed Description:

For MCS-2 This is a double-blind, randomized, placebo-controlled, parallel study where eligible male subjects (age 40, N=188), after a two-week washout period, will be randomized at 1:1 ratio to receive either MCS 30 mg/day or placebo for 12 weeks.

Group A: MCS 30 mg/day for 12 weeks Group B: placebo for 12 weeks

Subjects are limited to those who are currently not being treated medically for BPH or LUTS with alpha-blockers, anti-cholinergics, 5-alpha reductase inhibitors, or hormonal therapeutic agents. For each treatment arm, about 85 subjects eligible for final per protocol analysis will be recruited. Concerning an expected dropout rate of 10%, 188 subjects in total will be recruited onto the study.

For MCS-3 This is a double-blind, randomized, placebo-controlled, add-on, parallel study where eligible male subjects (age 40, N=242), after a two-week washout period, will be randomized at 1:1 ratio to receive either MCS 30 mg/day plus alpha-blocker or placebo plus alpha-blocker for 12 weeks.

Group A: alpha-blocker plus MCS 30 mg/day Group B: alpha-blocker plus placebo

Subjects are limited to those who are currently not being treated medically for BPH or LUTS with anti-cholinergics, 5-alpha reductase inhibitors, or hormonal therapeutic agents. For each treatment arm, about 220 subjects eligible for final per protocol analysis will be recruited. Concerning an expected dropout rate of 10%, 242 subjects in total will be recruited onto the study.

All participating subjects will be advised to maintain a normal diet as they do before joining the study. However, participating subjects are advised to refrain from extra source of carotenoids supplementation and MCS extracts made into a capsule, soft gel, or crude granule extracts.

  Eligibility

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

Inclusion criteria for subproject MCS-2

  • 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.

Exclusion criteria

  • 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.

Inclusion criteria for subproject MCS-3

  • 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.

Exclusion criteria

  • 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.
  • PSA > 10.0 ng/ml, abnormal DRE of the prostate or any suspicion of prostate malignancy. However, those who have a negative prostate biopsy are allowed.
  • 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: NCT00501371

Locations
Taiwan
Chang Gung Memorial Hospital
Chiayi, Taiwan, 613
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 807
Chung-Ho Memorial Hospital,Kaohsiung Medical University
Kaohsiung, Taiwan, 807
China Medical University Hospital
Taichung, Taiwan, 404
National Taiwan University Hospital
Taipei, Taiwan, 100
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: NCT00501371     History of Changes
Other Study ID Numbers: MCS for BPH-LUTS
Study First Received: July 10, 2007
Last Updated: December 13, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by Health Ever Bio-Tech Co., Ltd.:
Benign Prostatic Hyperplasia
MCS
Lower Urinary Tract Symptoms
International prostate symptom score
Voiding
Alpha-blockers

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

ClinicalTrials.gov processed this record on September 18, 2014