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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01002664 |
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Date of registration:
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20/10/2009 |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of MCS-2 in the Treatment of Lower Urinary Tract Symptoms
MCS_LUTS |
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Scientific title:
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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 |
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Date of first enrolment:
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May 2010 |
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Target sample size:
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225 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01002664 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Fu-Feng Kuo |
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Address:
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Telephone:
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+886-2-25788621 |
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Email:
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healthe@ms76.hinet.net |
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Affiliation:
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Name:
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Yeong-Shiau Pu, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Taiwan University Hospital |
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Key inclusion & exclusion criteria
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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.
Age minimum:
40 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Benign Prostatic Hyperplasia
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Lower Urinary Tract Symptoms
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Intervention(s)
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Drug: MCS-2
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Drug: Placebo
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Primary Outcome(s)
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Changes in total International Prostate Symptom Scores (I-PSS)
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Changes in I-PSS quality of life index
[Time Frame: 12 weels]
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Changes in I-PSS subscores
[Time Frame: 12 weeks]
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Changes in urinary peak flow rate
[Time Frame: 12 weeks]
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Incidence of treatment-emergent adverse events
[Time Frame: 12 weeks]
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Incidence of withdrawals due to treatment-emergent adverse events
[Time Frame: 12 weeks]
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Percentage of subjects with an I-PSS reduction = 4 points
[Time Frame: 12 weeks]
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Secondary ID(s)
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MCS-2-TWN-a
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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