Lower Urinary Tract SymptomsPhase 2/3MCS_LUTSNCT01002417
MCS in the Treatment of Lower Urinary Tract Symptoms
A Phase 2/3 study testing MCS-2 15 mg/day and MCS-2 30 mg/day 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
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. 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 15 mg/day and MCS-2 30 mg/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 274 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Feb 2014
- Phase
- Phase 2/3
- 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
- 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
Who cannot join
- 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
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: 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
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.
Read the 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).
- Being tested
- MCS-2 15 mg/day, MCS-2 30 mg/day, Placebo
- Keywords
- Benign Prostatic Hyperplasia, Multi-carotenoids, MCS-2, Lower Urinary Tract Symptoms, International prostate symptom scores
- 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-2 15 mg/dayDrug
Also called MUS
One MCS-2 15 mg soft-gel capsule plus one matching placebo capsule, oral daily for 12 weeks.
MCS-2 30 mg/dayDrug
Also called MUS
Two MCS-2 soft-gel capsules, oral daily for 12 weeks.
PlaceboDrug
Also called MCS matching placebo
Two matching placebo soft-gel capsules, oral daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Both the phase 2b and phase 3 parts of the study have the placebo arm. Receives: Drug: Placebo |
| MCS-2 15 mg/day | Active comparator | 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. Receives: Drug: MCS-2 15 mg/day; Drug: MCS-2 30 mg/day |
| MCS-2 30 mg/day | Active comparator | 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. Receives: Drug: MCS-2 15 mg/day; Drug: MCS-2 30 mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in International Prostate Symptom Scores
Measured: 12 weeks
Secondary outcomes (5)
Changes in I-PSS subscores
Measured: 12 weeks
Changes in I-PSS QOL index
Measured: 12 weeks
Changes in urine flow rate
Measured: 12 weels
Incidence of treatment-emergent adverse events (TEAE)
Measured: 12 weeks
Incidence of withdrawals due to TEAEs
Measured: 12 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 startJul 2010
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 274 participants (actual)
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
- NCT01002417
- Sponsor's protocol ID
- MCS-2-US-a
- Acronym
- MCS_LUTS
- 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
- 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
- ClinicalTrials.gov ID
- NCT01002417
- Acronym / sponsor ID
- MCS_LUTS / MCS-2-US-a
- Keywords
- Benign Prostatic Hyperplasia, Multi-carotenoids, MCS-2, Lower Urinary Tract Symptoms, International prostate symptom scores
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Health Ever Bio-Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- 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.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboBoth the phase 2b and phase 3 parts of the study have the placebo arm. |
| MCS-2 15 mg/day | Active comparator | Drug: MCS-2 15 mg/day, Drug: MCS-2 30 mg/dayFor 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. |
| MCS-2 30 mg/day | Active comparator | Drug: MCS-2 15 mg/day, Drug: MCS-2 30 mg/dayFor 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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-2 15 mg/dayAlso: MUSOne MCS-2 15 mg soft-gel capsule plus one matching placebo capsule, oral daily for 12 weeks. | Drug | MCS-2 15 mg/day, MCS-2 30 mg/day |
| MCS-2 30 mg/dayAlso: MUSTwo MCS-2 soft-gel capsules, oral daily for 12 weeks. | Drug | MCS-2 15 mg/day, MCS-2 30 mg/day |
| PlaceboAlso: MCS matching placeboTwo matching placebo soft-gel capsules, oral daily for 12 weeks. | Drug | Placebo |
Primary outcome
Changes from baseline in International Prostate Symptom Scores
Time frame: 12 weeks
5 secondary outcomes
Changes in I-PSS subscores
Time frame: 12 weeks
Changes in I-PSS QOL index
Time frame: 12 weeks
Changes in urine flow rate
Time frame: 12 weels
Incidence of treatment-emergent adverse events (TEAE)
Time frame: 12 weeks
Incidence of withdrawals due to TEAEs
Time frame: 12 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 2/3 study testing MCS-2 15 mg/day and MCS-2 30 mg/day 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 8 inclusion and 5 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Changes from baseline in International Prostate Symptom Scores (time frame: 12 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; AzTrials last refreshed its copy on 7 Nov 2026.