Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
274 participants
INTERVENTIONAL
2010-07-31
2014-02-28
Brief Summary
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Detailed Description
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Phase 2b Objectives: The primary objective of the Phase 2b portion of this study is to evaluate, in a treatment-naïve population, the 0 mg (placebo), 15 mg, and 30 mg MCS-2 in terms of dose response and to determine the optimal dose to be used in the Phase 3 portion of this trial. The secondary objective of this portion of the study is to evaluate the safety and tolerability of the 15 mg and 30 mg MCS-2.
Phase 3 Objectives: The primary objective of the Phase 3 portion of this study is to evaluate, in a treatment-naïve population, the effectiveness of the MCS-2 (at the dosage determined in the Phase 2b portion of this study), as compared to MCS placebo (0 mg), in reducing the lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). The secondary objective of this study is to evaluate the safety and tolerability of MCS-2 (at the dosage determined in the Phase 2b portion of this study), as compared to MCS placebo (0 mg).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Both the phase 2b and phase 3 parts of the study have the placebo arm.
Placebo
Two matching placebo soft-gel capsules, oral daily for 12 weeks.
MCS-2 15 mg/day
For 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 15 mg/day
One MCS-2 15 mg soft-gel capsule plus one matching placebo capsule, oral daily for 12 weeks.
MCS-2 30 mg/day
Two MCS-2 soft-gel capsules, oral daily for 12 weeks.
MCS-2 30 mg/day
For 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.
MCS-2 15 mg/day
One MCS-2 15 mg soft-gel capsule plus one matching placebo capsule, oral daily for 12 weeks.
MCS-2 30 mg/day
Two MCS-2 soft-gel capsules, oral daily for 12 weeks.
Interventions
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MCS-2 15 mg/day
One MCS-2 15 mg soft-gel capsule plus one matching placebo capsule, oral daily for 12 weeks.
MCS-2 30 mg/day
Two MCS-2 soft-gel capsules, oral daily for 12 weeks.
Placebo
Two matching placebo soft-gel capsules, oral daily for 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
MALE
No
Sponsors
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Health Ever Bio-Tech Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Allan J Pantuck, MD, MS, FACS
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
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David Geffen School of Medicine at UCLA
Los Angeles, California, United States
Countries
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Other Identifiers
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MCS-2-US-a
Identifier Type: -
Identifier Source: org_study_id
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