Benign Prostatic HyperplasiaPhase 4NCT00771394
Solifenacin as Add-on Therapy for Overactive Bladder Symptoms in Men Treated for Benign Prostatic Hyperplasia
A Phase 4 study testing Tamsulosin hydrochloride and Solifenacin succinate in people with Benign Prostatic Hyperplasia and Benign Prostatic Hypertrophy, run by Astellas Pharma Inc at 8 sites in Japan.
Trial summary
To evaluate the efficacy and safety of solifenacin succinate as add-on therapy for overactive bladder (OAB) symptoms in men who have been treated for benign prostatic hyperplasia (BPH) with tamsulosin hydrochloride for at least 6 weeks Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy, Overactive Bladder
- What is being tested?
- Tamsulosin hydrochloride and Solifenacin succinate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 638 participants
- Where
- 8 sitesJapan
- Study dates
- Oct 2008to Jan 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
- Patients with benign prostatic hypertrophy who have been treated with tamsulosin for at least 6 weeks
- Patients with urgency episodes and frequent micturitions
- Written informed consent has been obtained
- Uroflowmetry-Q max ≥ 5 mL/sec, and Post Void Residual Volume < 50 mL
Who cannot join
- Patients with suspected symptoms of OAB whose onset is only transient (drug-induced, psychogenic, etc.)
- Patients with obvious stress urinary incontinence
- Patients with complications or who have a past history of a bladder tumor
- Patients with urethral stricture or bladder neck stenosis
- Patients with a history of surgery causing damage to the pelvic plexus
- Patients with history of hypersensitivity to α receptor blockers, a/b receptor blockers, or anticholinergic drugs
- Patients with orthostatic hypotension, ulcerative colitis, hyperthyroidism, dementia or cognitive dysfunction, Parkinson's disease, or cerebrovascular disorder
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Study site
Chūbu
Study site
Chugoku
Study site
Hokkaido
Study site
Kansai
Study site
Kantou
Study site
Kyushu
Study site
Shikoku
Study site
Tōhoku
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study of Solifenacin Succinate as Add-on Therapy for Overactive Bladder (OAB) Symptoms in Men Treated for Benign Prostatic Hyperplasia (BPH) With Tamsulosin Hydrochloride
To evaluate the efficacy and safety of solifenacin succinate as add-on therapy for overactive bladder (OAB) symptoms in men who have been treated for benign prostatic hyperplasia (BPH) with tamsulosin hydrochloride for at least 6 weeks
Read the detailed description
Study drugs are administered for 14 weeks in total, including a 2-week run-in period (single blind) and a 12-week treatment period (double blind). After written informed consent, study drugs for the run-in period are orally administered once daily after breakfast for two weeks to subjects who fulfill the inclusion and exclusion criteria. Then, subjects are randomized and orally treated with study drugs for the treatment period once daily after breakfast for 12 weeks
- Being tested
- Tamsulosin hydrochloride, Solifenacin succinate
- Keywords
- Vesicare, Solifenacin succinate, Tamsulosin, Overactive Bladder, BPH
- Medical subject headings
- Prostatic Hyperplasia, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamsulosin hydrochlorideDrug
Also called Harnal, YM617
oral
Solifenacin succinateDrug
Also called Vesicare, YM905
oral
| Study group | Role | What they receive |
|---|---|---|
| 1. Tamsulosin alone | Placebo comparator | Not described Receives: Drug: Tamsulosin hydrochloride |
| 2. Tamsulosin + solifenacin (low dose) | Experimental | Not described Receives: Drug: Tamsulosin hydrochloride; Drug: Solifenacin succinate |
| 3. Tamsulosin + solifenacin (high dose) | Active comparator | Not described Receives: Drug: Tamsulosin hydrochloride; Drug: Solifenacin succinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mean number of urgency episodes per 24 hours
Measured: at 4, 8, 12 week
Secondary outcomes (4)
Mean number of micturitions per 24 hrs
Measured: at 4, 8, 12 week
Mean number of incontinence episodes per 24 hours
Measured: at 4, 8, 12 week
Mean number of micturitions per night
Measured: at 4, 8, 12 week
Adverse Events, Laboratory Tests
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionJan 2010
- Study completionJan 2010
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 638 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00771394
- Sponsor's protocol ID
- 905-JC-001
- Status last verified
- Feb 2013
- First submitted
- 9 Oct 2008
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study of Solifenacin Succinate as Add-on Therapy for Overactive Bladder (OAB) Symptoms in Men Treated for Benign Prostatic Hyperplasia (BPH) With Tamsulosin Hydrochloride
- ClinicalTrials.gov ID
- NCT00771394
- Acronym / sponsor ID
- 905-JC-001
- Keywords
- Vesicare, Solifenacin succinate, Tamsulosin, Overactive Bladder, BPH
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 638 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 13 Oct 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.
To evaluate the efficacy and safety of solifenacin succinate as add-on therapy for overactive bladder (OAB) symptoms in men who have been treated for benign prostatic hyperplasia (BPH) with tamsulosin hydrochloride for at least 6 weeks
Detailed description
Study drugs are administered for 14 weeks in total, including a 2-week run-in period (single blind) and a 12-week treatment period (double blind). After written informed consent, study drugs for the run-in period are orally administered once daily after breakfast for two weeks to subjects who fulfill the inclusion and exclusion criteria. Then, subjects are randomized and orally treated with study drugs for the treatment period once daily after breakfast for 12 weeks
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 |
|---|---|---|
| 1. Tamsulosin alone | Placebo comparator | Drug: Tamsulosin hydrochloride |
| 2. Tamsulosin + solifenacin (low dose) | Experimental | Drug: Tamsulosin hydrochloride, Drug: Solifenacin succinate |
| 3. Tamsulosin + solifenacin (high dose) | Active comparator | Drug: Tamsulosin hydrochloride, Drug: Solifenacin succinate |
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)
- Patients with benign prostatic hypertrophy who have been treated with tamsulosin for at least 6 weeks
- Patients with urgency episodes and frequent micturitions
- Written informed consent has been obtained
- Uroflowmetry-Q max ≥ 5 mL/sec, and Post Void Residual Volume < 50 mL
Key exclusion criteria (7 listed)
- Patients with suspected symptoms of OAB whose onset is only transient (drug-induced, psychogenic, etc.)
- Patients with obvious stress urinary incontinence
- Patients with complications or who have a past history of a bladder tumor
- Patients with urethral stricture or bladder neck stenosis
- Patients with a history of surgery causing damage to the pelvic plexus
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 |
|---|---|---|
| Tamsulosin hydrochlorideAlso: Harnal, YM617oral | Drug | 1. Tamsulosin alone, 2. Tamsulosin + solifenacin (low dose), 3. Tamsulosin + solifenacin (high dose) |
| Solifenacin succinateAlso: Vesicare, YM905oral | Drug | 2. Tamsulosin + solifenacin (low dose), 3. Tamsulosin + solifenacin (high dose) |
Primary outcome
Change from baseline in mean number of urgency episodes per 24 hours
Time frame: at 4, 8, 12 week
4 secondary outcomes
Mean number of micturitions per 24 hrs
Time frame: at 4, 8, 12 week
Mean number of incontinence episodes per 24 hours
Time frame: at 4, 8, 12 week
Mean number of micturitions per night
Time frame: at 4, 8, 12 week
Adverse Events, Laboratory Tests
Time frame: end of study
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 15 Feb 2013.
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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
8 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 Tamsulosin hydrochloride and Solifenacin succinate in people with Benign Prostatic Hyperplasia and Benign Prostatic Hypertrophy, run by Astellas Pharma Inc at 8 sites in Japan.
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 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Japan. 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?
Change from baseline in mean number of urgency episodes per 24 hours (time frame: at 4, 8, 12 week). 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 15 Feb 2013.