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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
History of Changes
  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:

U.S. FDA Resources

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
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:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013