Efficacy and Safety of MCS-2 in the Treatment of Lower Urinary Tract Symptoms (MCS_LUTS)
This study is currently recruiting participants.
Verified September 2012 by Health Ever Bio-Tech Co., Ltd.
Sponsor:
Health Ever Bio-Tech Co., Ltd.
Information provided by (Responsible Party):
Health Ever Bio-Tech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01002664
First received: October 20, 2009
Last updated: September 7, 2012
Last verified: September 2012
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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 Drug: Placebo |
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: | 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 |
Resource links provided by NLM:
Further study details as provided by Health Ever Bio-Tech Co., Ltd.:
Primary Outcome Measures:
- Changes in total International Prostate Symptom Scores (I-PSS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percentage of subjects with an I-PSS reduction ≥ 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 quality of life index [ Time Frame: 12 weels ] [ Designated as safety issue: No ]
- Changes in urinary peak flow rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Incidence of treatment-emergent adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Incidence of withdrawals due to treatment-emergent adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 225 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: MCS-2 |
Drug: MCS-2
30 mg/day (two 15 mg capsules) Qd for 12 weeks
Other Name: MUS
|
| Placebo Comparator: Placebo |
Drug: Placebo
2 soft-gel placebo capsules Qd for 12 weeks
Other Name: MCS Matching Placebo
|
Detailed Description:
Eligible male subjects will be randomized at 2:1 ratio to receive either MCS-2 or placebo for 12 weeks. Subjects are those not currently on any medicines for BPH or LUTS. During and at the end of the 12-week treatment period, randomized subjects will be evaluated for efficacy and safety parameters. All subjects will be advised to maintain a normal diet, similar to what was consumed before joining the study. However, participating subjects will be advised to avoid consuming foods with extra sources of lycopene. A list of restricted foods will be supplied at the Screening visit.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01002664
Contacts
| Contact: Fu-Feng Kuo | +886-2-25788621 | healthe@ms76.hinet.net |
Locations
| Taiwan | |
| Chang Gung Medical Foundation, Chiayi Branch | Recruiting |
| Chiayi, Taiwan | |
| Contact: Chih-Shou Chen, MD cv7589@adm.cgmh.org.tw | |
| Principal Investigator: Chih-Shou Chen, MD | |
| Chung-Ho Memorial Hospital, Kaohsiung Medical University | Recruiting |
| Kaohsiung, Taiwan | |
| Contact: Wen-Jeng Wu, MD, PhD wejewu@kmu.edu.tw | |
| Principal Investigator: Wen-Jeng Wu, MD, PhD | |
| Kaohsiung Veterans General Hospital | Recruiting |
| Kaohsiung, Taiwan | |
| Contact: Tong-Lin Wu, MD, MBA tonywu@isca.vghks.gov.tw | |
| Principal Investigator: Tong-Lin Wu, MD, MBA | |
| Chang Gung Medical Foundation, Kaohsiung Branch | Recruiting |
| Kaohsiung, Taiwan | |
| Contact: Po-Hui Chiang, MD, PhD cphtem@yahoo.com.tw | |
| Principal Investigator: Po-Hui Chiang, MD, PhD | |
| Chang Gung Medical Foundation, Keelung Branch | Recruiting |
| Keelung, Taiwan | |
| Contact: Wen-Hsiang Chen, MD c04336@cgmh.org.tw | |
| Principal Investigator: Wen-Hsiang Chen, MD | |
| China Medical University Hospital | Recruiting |
| Taichung, Taiwan | |
| Contact: Hsi-Chin Wu, MD wuhc@mail.cmu.edu.tw | |
| Principal Investigator: Hsi-Chin Wu, MD | |
| National Taiwan University Hospital | Recruiting |
| Taipei, Taiwan, 10002 | |
| Contact: Yeong-Shiau Pu, MD PhD yspu@ntu.edu.tw | |
| Principal Investigator: Yeong-Shiau Pu, MD PhD | |
| Tri-Service General Hospital | Recruiting |
| Taipei, Taiwan | |
| Contact: Tai-Lung Cha, MD, PhD tlcha@ndmctsgh.edu.tw | |
| Principal Investigator: Tai-Lung Cha, MD, PhD | |
| Chang Gung Medical Foundation, Linkou Branch | Recruiting |
| Taoyuan, Taiwan | |
| Contact: Cheng-Keng Chuang, MD, PhD chuang89@cgmh.org.tw | |
| Principal Investigator: Cheng-Keng Chuang, MD, PhD | |
Sponsors and Collaborators
Health Ever Bio-Tech Co., Ltd.
Investigators
| Principal Investigator: | Yeong-Shiau Pu, MD PhD | National Taiwan University Hospital |
More Information
No publications provided
| Responsible Party: | Health Ever Bio-Tech Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT01002664 History of Changes |
| Other Study ID Numbers: | MCS-2-TWN-a |
| Study First Received: | October 20, 2009 |
| Last Updated: | September 7, 2012 |
| Health Authority: | United States: Food and Drug Administration Taiwan: Department of Health |
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 21, 2013