Lower Urinary Tract SymptomsPhase 3MCS_LUTSNCT01002664
Efficacy and Safety of MCS-2 in the Treatment of Lower Urinary Tract Symptoms
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 Taiwan.
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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 272 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2010to Jun 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
- 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.
About this study
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
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
Eligible male subjects will be randomized 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.
- Being tested
- MCS-2, 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-2Drug
Also called MUS
30 mg/day (two 15 mg capsules) Qd for 12 weeks
PlaceboDrug
Also called MCS Matching Placebo
2 soft-gel placebo capsules Qd for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| MCS-2 | Active comparator | Drug Name: MCS-2 Dosage: 2 soft-gel capsules Frequency: Qd per day after dinner Duration: 12 weeks Receives: Drug: MCS-2 |
| Placebo | Placebo comparator | Drug Name: MCS-2 placebo Dosage: 2 soft-gel capsules Frequency: Qd per day after dinner Duration: 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in total International Prostate Symptom Scores (I-PSS)
Changes in total International Prostate Symptom Scores (I-PSS)
Measured: 12 weeks
Secondary outcomes (5)
Changes in I-PSS subscores
Changes in I-PSS subscores
Measured: 12 weeks
Changes in I-PSS quality of life index
Changes in I-PSS quality of life index
Measured: 12 weels
Changes in urinary peak flow rate
Changes in urinary peak flow rate
Measured: 12 weeks
Incidence of treatment-emergent adverse events
Incidence of treatment-emergent adverse events
Measured: 12 weeks
Incidence of withdrawals due to treatment-emergent adverse events
Incidence of withdrawals due to treatment-emergent adverse events
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 startMay 2010
- Primary completionJun 2014
- Study completionJun 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Ever Bio-Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yeong-Shiau Pu, MD PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01002664
- Sponsor's protocol ID
- MCS-2-TWN-a
- Acronym
- MCS_LUTS
- Status last verified
- Jul 2018
- First submitted
- 20 Oct 2009
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01002664
- Acronym / sponsor ID
- MCS_LUTS / MCS-2-TWN-a
- Keywords
- Benign Prostatic Hyperplasia, Multi-carotenoids, MCS-2, Lower Urinary Tract Symptoms, International prostate symptom scores
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Health Ever Bio-Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 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
Eligible male subjects will be randomized 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCS-2 | Active comparator | Drug: MCS-2Drug Name: MCS-2 Dosage: 2 soft-gel capsules Frequency: Qd per day after dinner Duration: 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboDrug Name: MCS-2 placebo Dosage: 2 soft-gel capsules Frequency: Qd per day after dinner Duration: 12 weeks |
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-2Also: MUS30 mg/day (two 15 mg capsules) Qd for 12 weeks | Drug | MCS-2 |
| PlaceboAlso: MCS Matching Placebo2 soft-gel placebo capsules Qd for 12 weeks | Drug | Placebo |
Primary outcome
Changes in total International Prostate Symptom Scores (I-PSS)
Time frame: 12 weeks
Changes in total International Prostate Symptom Scores (I-PSS)
5 secondary outcomes
Changes in I-PSS subscores
Time frame: 12 weeks
Changes in I-PSS quality of life index
Time frame: 12 weels
Changes in urinary peak flow rate
Time frame: 12 weeks
Incidence of treatment-emergent adverse events
Time frame: 12 weeks
Incidence of withdrawals due to treatment-emergent adverse events
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 2 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Yeong-Shiau Pu, MD PhD principal investigator
National Taiwan University Hospital
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 Taiwan.
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 2 Aug 2018. 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 Taiwan. 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 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?
Changes in total International Prostate Symptom Scores (I-PSS) (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 2 Aug 2018.