MCS in the Treatment of Lower Urinary Tract Symptoms
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Hematology, Benign Prostate Hyperplasia, Urology |
| Therapuetic Areas: | Hematology, Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 3/1/2014 |
| Start Date: | July 2010 |
| End Date: | December 2013 |
| Contact: | Fu-Feng Kuo |
| Email: | healthe@ms76.hinet.net |
| Phone: | +886-2-25788621 |
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
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.
treatment of lower urinary tract symptoms suggestive of benign prostatic hyperplasia.
This is an adaptive trial design, that combines elements of a Phase 2b (dose ranging) study
and a Phase 3 (hypothesis testing) study, the objectives for the two phases are separate.
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).
and a Phase 3 (hypothesis testing) study, the objectives for the two phases are separate.
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).
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
We found this trial at
1
site
10833 Le Conte Ave
Los Angeles, California 90095
Los Angeles, California 90095
(310) 825-4321
David Geffen School of Medicine, UCLA In 2002 Mr. David Geffen announced a $200 million...
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