Efficacy and Safety of MCS-2 in the Treatment of Lower Urinary Tract Symptoms
MCS_LUTS
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
1 other identifier
interventional
272
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2010
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2009
CompletedFirst Posted
Study publicly available on registry
October 27, 2009
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedAugust 2, 2018
July 1, 2018
4.1 years
October 20, 2009
July 31, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in total International Prostate Symptom Scores (I-PSS)
Changes in total International Prostate Symptom Scores (I-PSS)
12 weeks
Secondary Outcomes (5)
Changes in I-PSS subscores
12 weeks
Changes in I-PSS quality of life index
12 weels
Changes in urinary peak flow rate
12 weeks
Incidence of treatment-emergent adverse events
12 weeks
Incidence of withdrawals due to treatment-emergent adverse events
12 weeks
Study Arms (2)
MCS-2
ACTIVE COMPARATORDrug Name: MCS-2 Dosage: 2 soft-gel capsules Frequency: Qd per day after dinner Duration: 12 weeks
Placebo
PLACEBO COMPARATORDrug Name: MCS-2 placebo Dosage: 2 soft-gel capsules Frequency: Qd per day after dinner Duration: 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, 10002, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yeong-Shiau Pu, MD PhD
National Taiwan University Hospital
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
October 20, 2009
First Posted
October 27, 2009
Study Start
May 1, 2010
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
August 2, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share