Open-Label Extension Study of MCS-2 in the Treatment of Lower Urinary Tract Symptoms (MCS-2-US-c)
| 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: | January 2011 |
| End Date: | December 2013 |
| Contact: | Fu-Feng Kuo |
| Email: | healthe@ms76.hinet.net |
| Phone: | +886-2-25788621 |
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
This is an open-label extension study of another study protocol, MCS-2-US-a. Subjects who
have completed the 12-week treatment and procedures under the protocol MCS-2-US-a will be
eligible for another 24 weeks of MCS-2 treatment. Optimal dosage of MCS-2 as the active
treatment given under the protocol MCS-2-US-a phase 3 part will be given daily in the
extension period. No placebo arm is planned in the study.
have completed the 12-week treatment and procedures under the protocol MCS-2-US-a will be
eligible for another 24 weeks of MCS-2 treatment. Optimal dosage of MCS-2 as the active
treatment given under the protocol MCS-2-US-a phase 3 part will be given daily in the
extension period. No placebo arm is planned in the study.
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
optimal dose selected after the phase 2b part of MCS-2-US-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.
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
optimal dose selected after the phase 2b part of MCS-2-US-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.
Inclusion Criteria:
- Subject has completed 12 weeks of treatment under the protocol MCS-2-US-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-US-a.
- Subject is considered ineligible for the study by the investigator(s).
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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