MCS in the Treatment of Lower Urinary Tract Symptoms
MCS_LUTS
An Adaptive, Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Study to Establish the Dosage, Efficacy, and Safety of MCS-2 in Treating Lower Urinary Tract Symptoms Suggestive of BPH in Treatment-Naive Male Subjects
1 other identifier
interventional
274
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 P75+ for phase_2
Started Jul 2010
Typical duration for phase_2
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 25, 2009
CompletedFirst Posted
Study publicly available on registry
October 27, 2009
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedMarch 3, 2015
March 1, 2015
3.6 years
October 25, 2009
March 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes from baseline in International Prostate Symptom Scores
12 weeks
Secondary Outcomes (5)
Changes in I-PSS subscores
12 weeks
Changes in I-PSS QOL index
12 weeks
Changes in urine flow rate
12 weels
Incidence of treatment-emergent adverse events (TEAE)
12 weeks
Incidence of withdrawals due to TEAEs
12 weeks
Study Arms (3)
Placebo
PLACEBO COMPARATORBoth the phase 2b and phase 3 parts of the study have the placebo arm.
MCS-2 15 mg/day
ACTIVE COMPARATORFor the phase 2b part of the study. It can also be used in the phase 3 part of the study if MCS-2 15 mg/day is selected as the optimal dosage.
MCS-2 30 mg/day
ACTIVE COMPARATORFor the phase 2b part of the study. It can also be used in the phase 3 part of the study if MCS-2 30 mg/day is selected as the optimal dosage.
Interventions
One MCS-2 15 mg soft-gel capsule plus one matching placebo capsule, oral daily for 12 weeks.
Two MCS-2 soft-gel capsules, oral daily for 12 weeks.
Two matching placebo soft-gel capsules, oral daily for 12 weeks.
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)
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Allan J Pantuck, MD, MS, FACS
University of California, Los Angeles
Study Design
- Study Type
- interventional
- Phase
- phase 2
- 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 25, 2009
First Posted
October 27, 2009
Study Start
July 1, 2010
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
March 3, 2015
Record last verified: 2015-03