Lower Urinary Tract SymptomsPhase 3MCS-2-US-cNCT01002222
Open-Label Extension Study of MCS-2 in the Treatment of Lower Urinary Tract Symptoms (MCS-2-US-c)
A Phase 3 study testing MCS-2 in people with Lower Urinary Tract Symptoms and Benign Prostatic Hyperplasia, run by Health Ever Bio-Tech Co., Ltd. at 1 site in United States.
Trial summary
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 this study. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia
- What is being tested?
- MCS-2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Feb 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
About this study
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
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 this study.
Read the 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 40 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.
- Being tested
- MCS-2
- Keywords
- Benign Prostatic Hyperplasia, MCS-2, Multi-Carotenoids, Lower Urinary Tract Symptoms, International prostate symptom score
- Medical subject headings
- Lower Urinary Tract Symptoms, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCS-2Drug
Also called MUS
15 or 30 mg/day of MCS-2 soft-gel capsules Qd for 24 weeks, depending on which dose level is selected after the phase 2b part of the protocol MCS-2-US-a.
| Study group | Role | What they receive |
|---|---|---|
| MCS-2 | Experimental | Not described Receives: Drug: MCS-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAE)
Measured: 36 weeks
Secondary outcomes (3)
Changes from baseline in International Prostate Symptom Score (I-PSS)
Measured: 36 weeks
Changes from baseline in urine flow rate
Measured: 36 weeks
Changes from baseline in serum lycopene levels
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startJan 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Health Ever Bio-Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Allan J Pantuck, MD, MS, FACS, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01002222
- Sponsor's protocol ID
- MCS-2-US-c
- Acronym
- MCS-2-US-c
- Status last verified
- Mar 2015
- First submitted
- 25 Oct 2009
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01002222
- Acronym / sponsor ID
- MCS-2-US-c / MCS-2-US-c
- Keywords
- Benign Prostatic Hyperplasia, MCS-2, Multi-Carotenoids, Lower Urinary Tract Symptoms, International prostate symptom score
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Health Ever Bio-Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 27 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 this study.
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 40 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MCS-2 | Experimental | Drug: MCS-2 |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MCS-2Also: MUS15 or 30 mg/day of MCS-2 soft-gel capsules Qd for 24 weeks, depending on which dose level is selected after the phase 2b part of the protocol MCS-2-US-a. | Drug | MCS-2 |
Primary outcome
Incidence of treatment-emergent adverse events (TEAE)
Time frame: 36 weeks
3 secondary outcomes
Changes from baseline in International Prostate Symptom Score (I-PSS)
Time frame: 36 weeks
Changes from baseline in urine flow rate
Time frame: 36 weeks
Changes from baseline in serum lycopene levels
Time frame: 36 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allan J Pantuck, MD, MS, FACS principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MCS-2 in people with Lower Urinary Tract Symptoms and Benign Prostatic Hyperplasia, run by Health Ever Bio-Tech Co., Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (TEAE) (time frame: 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2015.