Open-Label Extension Study of MCS-2 in the Treatment of Lower Urinary Tract Symptoms (MCS-2-TWN-c)
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:
NCT01002274
First received: October 21, 2009
Last updated: September 7, 2012
Last verified: September 2012
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Purpose
This is an open-label extension study of another study protocol, MCS-2-TWN-a. Subjects who have completed the 12-week treatment and procedures under the protocol MCS-2-TWN-a will be eligible for another 24 weeks of MCS-2 treatment. Same dosage of MCS-2 as the active treatment given under the protocol MCS-2-TWN-a will be given daily in the extension period. No placebo arm is planned in the study.
| Condition | Intervention | Phase |
|---|---|---|
|
Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia |
Drug: MCS-2 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open-Label, Six-Month Extension of Protocol MCS-2-TWN-a to Further Evaluate the Efficacy and Safety of MCS-2 for the Treatment of 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:
- Incidence of treatment-emergent adverse events [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Changes from baseline in International Prostate Symptom Scores (I-PSS) [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
- Changes from baseline in urine flow rate [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
- Changes from baseline in serum lycopene levels [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: MCS-2
2 soft-gel capsules Qd for 24 weeks
|
Drug: MCS-2
2 soft-gel capsules Qd for 24 weeks
Other Name: MUS
|
Detailed Description:
This open-label extension study is designed to further assess the long-term safety and efficacy of MCS-2. Subjects who have completed the 12-week treatment and procedures under the protocol MCS-2-TWN-a will be eligible for another 24 weeks of MCS-2 treatment at the same daily dosage as the active treatment given under the protocol MCS-2-TWN-a.
Subjects are limited to those who are currently not being treated medically for BPH or LUTS. Subjects will return for visits every 8 weeks for evaluation. Subjects can take lycopene-containing vegetables and fruits during this open-label extension study, but they are advised to refrain from extra source of lycopene supplementation, such as lycopene extracts made into a capsule, soft gel, or crude granule extracts.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject has completed 12 weeks of treatment under the protocol MCS-2-TWN-a.
- Subject is able to understand and willing to conform to the study procedures and has signed the informed consent form for participation in this extension study.
Exclusion Criteria:
- Subject has severe LUTS at the last visit under the protocol MCS-2-TWN-a.
- Subject is considered ineligible for the study by the investigator(s).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01002274
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 | |
| 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: | NCT01002274 History of Changes |
| Other Study ID Numbers: | MCS-2-TWN-c |
| Study First Received: | October 21, 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 BPH MCS-2 |
Multi-Carotenoids Lower Urinary Tract Symptoms International prostate symptom score |
Additional relevant MeSH terms:
|
Prostatic Hyperplasia Hyperplasia Prostatic Diseases Genital Diseases, Male Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013