MCS in the Treatment of Lower Urinary Tract Symptoms (MCS_LUTS)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia |
Drug: MCS-2 15 mg/day Drug: MCS-2 30 mg/day Drug: Placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
- Changes from baseline in International Prostate Symptom Scores [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Percentage of subjects who achieve an I-PSS reduction of ≥4 points [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Changes in I-PSS subscores [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Changes in I-PSS QOL index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Changes in urine flow rate [ Time Frame: 12 weels ] [ Designated as safety issue: No ]
- Incidence of treatment-emergent adverse events (TEAE) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Incidence of withdrawals due to TEAEs [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 262 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Both the phase 2b and phase 3 parts of the study have the placebo arm.
|
Drug: Placebo
Two matching placebo soft-gel capsules, oral daily for 12 weeks.
Other Name: MCS matching placebo
|
|
Active Comparator: 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.
|
Drug: MCS-2 15 mg/day
One MCS-2 15 mg soft-gel capsule plus one matching placebo capsule, oral daily for 12 weeks.
Other Name: MUS
Drug: MCS-2 30 mg/day
Two MCS-2 soft-gel capsules, oral daily for 12 weeks.
Other Name: MUS
|
|
Active Comparator: 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.
|
Drug: MCS-2 15 mg/day
One MCS-2 15 mg soft-gel capsule plus one matching placebo capsule, oral daily for 12 weeks.
Other Name: MUS
Drug: MCS-2 30 mg/day
Two MCS-2 soft-gel capsules, oral daily for 12 weeks.
Other Name: MUS
|
Detailed Description:
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).
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Fu-Feng Kuo | +886-2-25788621 | healthe@ms76.hinet.net |
| United States, California | |
| David Geffen School of Medicine at UCLA | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Allan J Pantuck, MD, MS, FACS Apantuck@mednet.ucla.edu | |
| Principal Investigator: Allan J Pantuck, MD, MS, FACS | |
| Principal Investigator: | Allan J Pantuck, MD, MS, FACS | University of California, Los Angeles |
More Information
No publications provided
| Responsible Party: | Health Ever Bio-Tech Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT01002417 History of Changes |
| Other Study ID Numbers: | MCS-2-US-a |
| Study First Received: | October 25, 2009 |
| Last Updated: | September 7, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Health Ever Bio-Tech Co., Ltd.:
|
Benign Prostatic Hyperplasia Multi-carotenoids MCS-2 Lower Urinary Tract Symptoms International prostate symptom scores |
Additional relevant MeSH terms:
|
Prostatic Hyperplasia Hyperplasia Prostatic Diseases Genital Diseases, Male Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013