Urinary Bladder, OveractivePhase 4NCT00699049
A Study Comparing the Efficacy of an Alpha Blocker Versus an Alpha Blocker Plus Solifenacin in Men With Overactive Bladder
A Phase 4 study testing Alpha blocker and solifenacin in people with Urinary Bladder, Overactive, run by KYU-SUNG LEE at 3 sites in South Korea.
Trial summary
The purpose of this study is to explore additional benefit of solifenacin after 12-week treatment, compared with alpha blocker monotherapy in men with residual OAB symptoms. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Urinary Bladder, Overactive
- What is being tested?
- Alpha blocker and solifenacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Jun 2008to Mar 2010
- Phase
- Phase 4
- 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persistent symptoms of OAB as verified by the 3 day voiding diary, defined by:
- symptoms of urinary urgency (defined as a level of >=3 in a 5 point urgency scale) at least two episode per 24 hours and
- symptoms of urinary frequency ( >8 micturitions per 24 hours)
- On a stable dose of tamsulosin for at least 1 month
Who cannot join
- Previous history of acute urinary retention
- Patients have a baseline post-void residual (PVR) which exceeded 50% of voided urine volume
- Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention
- Symptomatic acute urinary tract infection (UTI) during the screening period
- Treatment within the 14 days preceding randomization, or expected to initiate treatment during the study with any anticholinergic drugs and drug treatment for overactive bladder
- A 5-alpha reductase inhibitor if started less than 3 months prior to screening
- Patients with previous urethral, prostate or bladder neck surgery
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: A Randomized, Double Blind, Placebo-Controlled, Parallel Group Comparison of the Efficacy and Safety of Any Alpha Blocker Monotherapy and Any Alpha Blocker Plus Solifenacin in Men With Residual Overactive Bladder Symptoms of Urinary Frequency and Urgency With/Without Urgency Incontinence After Previous Monotherapy With Any Alpha Blocker
The purpose of this study is to explore additional benefit of solifenacin after 12-week treatment, compared with alpha blocker monotherapy in men with residual OAB symptoms.
- Conditions
- Urinary Bladder, Overactive
- Being tested
- Alpha blocker, placebo, solifenacin
- Keywords
- Alpha blocker, Tamsulosin, Solifenacin, Overactive Bladder, Urgency incontinence
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha blockerDrug
oral
placeboDrug
oral
solifenacinDrug
Also called Vesicare, YM905
oral
| Study group | Role | What they receive |
|---|---|---|
| Alpha blocker and placebo | Placebo comparator | Not described Receives: Drug: Alpha blocker; Drug: placebo |
| Alpha blocker and solifenacin | Experimental | Not described Receives: Drug: Alpha blocker; Drug: solifenacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement level of patients' individual satisfaction
Measured: At weeks 4 and 12
Secondary outcomes (3)
Changes in urgency episodes
Measured: At weeks 4 and 12
Changes in OAB symptom scores
Measured: At weeks 4 and 12
Changes in QoL score by OAB-q
Measured: At weeks 4 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder, OveractiveStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- KYU-SUNG LEE
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Korea, Inc.
- Responsible party
- Sponsor-investigator, KYU-SUNG LEE, Samsung Medical Center
- Investigators
- Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699049
- Sponsor's protocol ID
- SMK-1
- Status last verified
- Jan 2016
- First submitted
- 16 Jun 2008
- Last updated
- 7 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-Controlled, Parallel Group Comparison of the Efficacy and Safety of Any Alpha Blocker Monotherapy and Any Alpha Blocker Plus Solifenacin in Men With Residual Overactive Bladder Symptoms of Urinary Frequency and Urgency With/Without Urgency Incontinence After Previous Monotherapy With Any Alpha Blocker
- ClinicalTrials.gov ID
- NCT00699049
- Acronym / sponsor ID
- SMK-1
- Conditions
- Urinary Bladder, Overactive
- Keywords
- Alpha blocker, Tamsulosin, Solifenacin, Overactive Bladder, Urgency incontinence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- KYU-SUNG LEEUniversity, hospital or other
- Collaborators
- Astellas Pharma Korea, Inc.
- Study start
- Jun 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 17 Jun 2008 (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 purpose of this study is to explore additional benefit of solifenacin after 12-week treatment, compared with alpha blocker monotherapy in men with residual OAB symptoms.
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 |
|---|---|---|
| Alpha blocker and placebo | Placebo comparator | Drug: Alpha blocker, Drug: placebo |
| Alpha blocker and solifenacin | Experimental | Drug: Alpha blocker, Drug: solifenacin |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Persistent symptoms of OAB as verified by the 3 day voiding diary, defined by:
- On a stable dose of tamsulosin for at least 1 month
Key exclusion criteria (7 listed)
- Previous history of acute urinary retention
- Patients have a baseline post-void residual (PVR) which exceeded 50% of voided urine volume
- Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention
- Symptomatic acute urinary tract infection (UTI) during the screening period
- Treatment within the 14 days preceding randomization, or expected to initiate treatment during the study with any anticholinergic drugs and drug treatment for overactive bladder
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 |
|---|---|---|
| Alpha blockeroral | Drug | Alpha blocker and placebo, Alpha blocker and solifenacin |
| placebooral | Drug | Alpha blocker and placebo |
| solifenacinAlso: Vesicare, YM905oral | Drug | Alpha blocker and solifenacin |
Primary outcome
Achievement level of patients' individual satisfaction
Time frame: At weeks 4 and 12
3 secondary outcomes
Changes in urgency episodes
Time frame: At weeks 4 and 12
Changes in OAB symptom scores
Time frame: At weeks 4 and 12
Changes in QoL score by OAB-q
Time frame: At weeks 4 and 12
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 7 Jan 2016.
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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.
Central Contact study chair
Astellas Pharma Inc
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alpha blocker and solifenacin in people with Urinary Bladder, Overactive, run by KYU-SUNG LEE at 3 sites in South Korea.
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 4 inclusion and 7 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 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Achievement level of patients' individual satisfaction (time frame: At weeks 4 and 12). 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 7 Jan 2016.