Benign Prostatic HyperplasiaPhase 3NCT00501371
MCS in Treating Lower Urinary Tract Symptoms (LUTS) Suggestive of Benign Prostatic Hyperplasia
A Phase 3 study testing MCS in people with Benign Prostatic Hyperplasia, run by Health Ever Bio-Tech Co., Ltd. at 5 sites in Taiwan.
Trial summary
Phase III, Randomized, double-blind, parallel placebo-controlled study. Two arms: MCS (30mg/day) vs. placebo. Subproject MCS-2: alpha-blocker naïve subjects Subproject MCS-3: subjects responding poorly to alpha-blocker Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- MCS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 5 sitesTaiwan
- Study dates
- Jul 2007to Oct 2009
- 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 with Alpha-blocker, anti-cholinergics, 5-alpha reductase inhibitors, or hormonal agents.
- PSA≦4 ng/ml within 4 weeks of V1 and no pathologically-proven prostate cancer.
- No known malignancy, except cancers without signs of recurrence for > 5 years and no need for further anti-cancer treatment.
- AST/ALT≦3X UNL.
- creatinine≦3X UNL.
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- Subjects who sign the informed consent form.
- Age≧40 years old.
- The alpha-blocker dosage used should be as high as subjects can tolerate.
- No known malignancy, except cancers without signs of recurrence for > 5 years and no need for further anti-cancer treatment.
- PSA≦10.0 ng/ml without pathologically-proven prostate cancer or other cancers. Prostate biopsy is mandatory > 12 weeks before screening, if PSA is≧4 ng/ml to rule out prostate cancer.
- AST/ALT≦3X UNL.
- Creatinine≦3X UNL.
- Subjects who sign the informed consent form.
Who cannot join
- Subjects' LUTS are not BPH-related but are associated with such conditions as urethral stricture, prostatitis, neurogenic bladder, or pelvic treatment procedures.
- Have been treated with pelvis irradiation or pelvic surgery.
- Plan to undergo any invasive procedures within the study period, such as, prostate surgery, prostate biopsy, cystourethroscopy, pelvic surgery, laparotomy, or any procedures needing urethral catheterization.
- Participating in another investigational agent study in the past 12 weeks or are going to do so during the study period.
- Active infection or inflammation.
- Considered ineligible by the investigators.
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- Subjects' LUTS are not BPH-related but associated with such conditions as urethral stricture, prostatitis, neurogenic bladder, or pelvic treatment procedures.
- Subjects who have been treated with pelvis irradiation or pelvic surgery.
- PSA > 10.0 ng/ml, abnormal DRE of the prostate or any suspicion of prostate malignancy. However, those who have a negative prostate biopsy are allowed.
- Active infection or inflammation.
- Considered ineligible by the investigators.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Taiwan5 sites
Chang Gung Memorial Hospital
Chiayi City, 613
Chung-Ho Memorial Hospital,Kaohsiung Medical University
Kaohsiung City, 807
Kaohsiung Veterans General Hospital
Kaohsiung City, 807
China Medical University Hospital
Taichung, 404
National Taiwan University Hospital
Taipei, 100
About this study
Official title: Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of MCS in Treating Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia
Phase III, Randomized, double-blind, parallel placebo-controlled study. Two arms: MCS (30mg/day) vs. placebo.
Subproject MCS-2: alpha-blocker naïve subjects
Subproject MCS-3: subjects responding poorly to alpha-blocker
Read the detailed description
For MCS-2 This is a double-blind, randomized, placebo-controlled, parallel study where eligible male subjects (age 40, N=188), after a two-week washout period, will be randomized at 1:1 ratio to receive either MCS 30 mg/day or placebo for 12 weeks.
Group A: MCS 30 mg/day for 12 weeks Group B: placebo for 12 weeks
Subjects are limited to those who are currently not being treated medically for BPH or LUTS with alpha-blockers, anti-cholinergics, 5-alpha reductase inhibitors, or hormonal therapeutic agents. For each treatment arm, about 85 subjects eligible for final per protocol analysis will be recruited. Concerning an expected dropout rate of 10%, 188 subjects in total will be recruited onto the study.
For MCS-3 This is a double-blind, randomized, placebo-controlled, add-on, parallel study where eligible male subjects (age 40, N=242), after a two-week washout period, will be randomized at 1:1 ratio to receive either MCS 30 mg/day plus alpha-blocker or placebo plus alpha-blocker for 12 weeks.
Group A: alpha-blocker plus MCS 30 mg/day Group B: alpha-blocker plus placebo
Subjects are limited to those who are currently not being treated medically for BPH or LUTS with anti-cholinergics, 5-alpha reductase inhibitors, or hormonal therapeutic agents. For each treatment arm, about 220 subjects eligible for final per protocol analysis will be recruited. Concerning an expected dropout rate of 10%, 242 subjects in total will be recruited onto the study.
All participating subjects will be advised to maintain a normal diet as they do before joining the study. However, participating subjects are advised to refrain from extra source of carotenoids supplementation and MCS extracts made into a capsule, soft gel, or crude granule extracts.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- MCS, Placebo
- Keywords
- Benign Prostatic Hyperplasia, MCS, Lower Urinary Tract Symptoms, International prostate symptom score, Voiding, Alpha-blockers
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCSDrug
Also called MUS
soft-gel capsule, 15 mg/cap., Qd, 12 weeks
PlaceboDrug
Also called MUS
soft-gel capsule, Qd, 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| MCS | Active comparator | Group A: MCS 30 mg/day for 12 weeks Receives: Drug: MCS |
| Placebo | Placebo comparator | Placebo, 2 capsules per day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
MCS-2: To compare changes in I-PSS points after 12 weeks of MCS or placebo supplementation.
Measured: 12 weeks
MCS-3: To compare the percentage of subjects who achieve an I-PSS reduction by 4 or more points from baseline at 12 weeks between the MCS and the placebo arms.
Measured: 12 weeks
Secondary outcomes (1)
To evaluate the general safety and tolerability.
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 posted16 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionOct 2009
- Study completionOct 2009
Why it stopped: Study terminated for re-design. A new IND study (US FDA, July 2009) will be conducted in US and Taiwan. Termination not related to safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies 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
- 85 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
- NCT00501371
- Sponsor's protocol ID
- MCS for BPH-LUTS
- Status last verified
- Dec 2011
- First submitted
- 10 Jul 2007
- Last updated
- 14 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of MCS in Treating Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT00501371
- Acronym / sponsor ID
- MCS for BPH-LUTS
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Benign Prostatic Hyperplasia, MCS, Lower Urinary Tract Symptoms, International prostate symptom score, Voiding, Alpha-blockers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated for re-design. A new IND study (US FDA, July 2009) will be conducted in US and Taiwan. Termination not related to safety concerns.
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Health Ever Bio-Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 16 Jul 2007 (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.
Phase III, Randomized, double-blind, parallel placebo-controlled study. Two arms: MCS (30mg/day) vs. placebo.
Subproject MCS-2: alpha-blocker naïve subjects
Subproject MCS-3: subjects responding poorly to alpha-blocker
Detailed description
For MCS-2 This is a double-blind, randomized, placebo-controlled, parallel study where eligible male subjects (age 40, N=188), after a two-week washout period, will be randomized at 1:1 ratio to receive either MCS 30 mg/day or placebo for 12 weeks.
Group A: MCS 30 mg/day for 12 weeks Group B: placebo for 12 weeks
Subjects are limited to those who are currently not being treated medically for BPH or LUTS with alpha-blockers, anti-cholinergics, 5-alpha reductase inhibitors, or hormonal therapeutic agents. For each treatment arm, about 85 subjects eligible for final per protocol analysis will be recruited. Concerning an expected dropout rate of 10%, 188 subjects in total will be recruited onto the study.
For MCS-3 This is a double-blind, randomized, placebo-controlled, add-on, parallel study where eligible male subjects (age 40, N=242), after a two-week washout period, will be randomized at 1:1 ratio to receive either MCS 30 mg/day plus alpha-blocker or placebo plus alpha-blocker for 12 weeks.
Group A: alpha-blocker plus MCS 30 mg/day Group B: alpha-blocker plus placebo
Subjects are limited to those who are currently not being treated medically for BPH or LUTS with anti-cholinergics, 5-alpha reductase inhibitors, or hormonal therapeutic agents. For each treatment arm, about 220 subjects eligible for final per protocol analysis will be recruited. Concerning an expected dropout rate of 10%, 242 subjects in total will be recruited onto the study.
All participating subjects will be advised to maintain a normal diet as they do before joining the study. However, participating subjects are advised to refrain from extra source of carotenoids supplementation and MCS extracts made into a capsule, soft gel, or crude granule extracts.
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 | Active comparator | Drug: MCSGroup A: MCS 30 mg/day for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, 2 capsules per day |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≧ 40 years old.
- Not being treated for BPH or LUTS with Alpha-blocker, anti-cholinergics, 5-alpha reductase inhibitors, or hormonal agents.
- PSA≦4 ng/ml within 4 weeks of V1 and no pathologically-proven prostate cancer.
- No known malignancy, except cancers without signs of recurrence for > 5 years and no need for further anti-cancer treatment.
- AST/ALT≦3X UNL.
Key exclusion criteria (11 listed)
- Subjects' LUTS are not BPH-related but are associated with such conditions as urethral stricture, prostatitis, neurogenic bladder, or pelvic treatment procedures.
- Have been treated with pelvis irradiation or pelvic surgery.
- Plan to undergo any invasive procedures within the study period, such as, prostate surgery, prostate biopsy, cystourethroscopy, pelvic surgery, laparotomy, or any procedures needing urethral catheterization.
- Participating in another investigational agent study in the past 12 weeks or are going to do so during the study period.
- Active infection or inflammation.
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 |
|---|---|---|
| MCSAlso: MUSsoft-gel capsule, 15 mg/cap., Qd, 12 weeks | Drug | MCS |
| PlaceboAlso: MUSsoft-gel capsule, Qd, 12 weeks | Drug | Placebo |
Primary outcome
MCS-2: To compare changes in I-PSS points after 12 weeks of MCS or placebo supplementation.
Time frame: 12 weeks
MCS-3: To compare the percentage of subjects who achieve an I-PSS reduction by 4 or more points from baseline at 12 weeks between the MCS and the placebo arms.
Time frame: 12 weeks
1 secondary outcome
To evaluate the general safety and tolerability.
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Study terminated for re-design. A new IND study (US FDA, July 2009) will be conducted in US and Taiwan. Termination not related to safety concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2011.
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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
5 sites 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 in people with Benign Prostatic Hyperplasia, run by Health Ever Bio-Tech Co., Ltd. at 5 sites 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 14 inclusion and 11 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: stopped early, as of the sponsor's last update on 14 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 was stopped early (reason given: Study terminated for re-design. A new IND study (US FDA, July 2009) will be conducted in US and Taiwan. Termination not related to safety concerns.). Results are not available in the source record.
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?
MCS-2: To compare changes in I-PSS points after 12 weeks of MCS or placebo supplementation. (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 14 Dec 2011.