Overactive BladderPhase 4NCT01745094
A Study to Evaluate the Effect of Mirabegron + Solifenacin in Overactive Bladder Patients
A Phase 4 study testing mirabegron and solifenacin in people with Overactive Bladder, run by Astellas Pharma Inc at 5 sites in Japan.
Trial summary
The purpose of this study was to evaluate the safety and efficacy of mirabegron as add-on therapy in patients with OAB treated with solifenacin. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- mirabegron and solifenacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 5 sitesJapan
- Study dates
- 1 Oct 2012to 23 Jul 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female: postmenopausal OAB outpatient
- Male: OAB outpatient who did not wish to have children at all
- Patient had been treated with solifenacin at a stable dose once daily for at least 4 weeks prior to the study
- Patient had a total OAB symptom score (OABSS ) score of ≥3 points and a Question 3 score ≥2 points
Who cannot join
- Patient had a residual urine volume of ≥100 mL or a maximum flow rate <5 mL/s, or patients with benign prostatic hyperplasia, or lower urinary tract obstruction
- Patient had serious heart disease (myocardial infarction, cardiac failure, uncontrolled angina pectoris, serious arrhythmia, use of pacemaker, etc.), liver disease, kidney disease, immunological disease, lung disease, etc. or patient had malignant tumor (except for malignant tumor that has not been treated for at least 5 y before the start of the screening period with no risk of recurrence)
- Patient had received surgical therapy that may affect the urinary tract function within 24 weeks before the start of the screening period
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Japan5 sites
Study site
Chūbu
Study site
Hokkaido
Study site
Kansai
Study site
Kantou
Study site
Kyushu
About this study
Official title: Safety and Efficacy of Mirabegron as Add-on Therapy in Patients With Overactive Bladder Treated With Solifenacin: A Postmarketing Open-label Study in Japan
The purpose of this study was to evaluate the safety and efficacy of mirabegron as add-on therapy in patients with OAB treated with solifenacin.
Read the detailed description
The total duration of the study was 18 weeks, comprising a 2-week screening period and a 16-week treatment period. Patients meeting the eligibility criteria for provisional enrollment received the study drug for the screening period (solifenacin) at the same dose as that before the start of the study (2.5 or 5 mg), once daily after breakfast orally for 2 weeks. After the screening period, patients meeting the eligibility criteria for formal enrollment received the study drugs for the treatment period (solifenacin 2.5 or 5 mg and mirabegron 25 mg), once daily after breakfast orally for 16 weeks. Mirabegron dose could be increased to 50 mg at week 8 visit if the patients met all of the following criteria: (1) had an inadequate response to mirabegron at the dose of 25 mg; (2) was judged by the investigator or coinvestigator to have no safety concerns; and (3) agreed to increase the dose.
- Conditions
- Overactive Bladder
- Being tested
- mirabegron, solifenacin
- Keywords
- mirabegron, solifenacin
- 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.
mirabegronDrug
Also called YM178, Betanis
oral
solifenacinDrug
Also called Vesicare, YM905
oral
| Study group | Role | What they receive |
|---|---|---|
| Concomitant Group | Experimental | concomitant administration of mirabegron to solifenacin treated patients Receives: Drug: mirabegron; Drug: solifenacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAEs were defined as AEs observed after the first administration of the study drugs for the treatment period. The investigator assessed the severity of AEs, including abnormal clinical laboratory values, Electrocardiogram (ECG), vital signs, as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. A drug-related TEAE was a TEAE with at least a possible relationship to the study drug as assessed by the investigator.
Measured: From first dose of study drug up to weeks 16
Secondary outcomes (14)
Change From Baseline in OABSS Total Score
The OABSS questionnaire was a questionnaire completed by participants with 4 questions regarding their OAB symptoms. For each participant, the OABSS total score was calculated from the sum total of the score of each question. The total score ranges from 0 to 15 with higher score indicating more symptoms. The OABSS data obtained at week 0 were used as baseline.
Measured: Baseline and week 8, 16
Number of Participants Who Achieved Normalization for OABSS Total Score
Normalization for OABSS Total Score was defined as OABSS total score ≤ 2 or OABSS Question 3 score ≤ 1.
Measured: Week 8 and 16
Change From Baseline in Overactive Bladder Questionnaire Short Form (OAB-q SF) Severity Score
The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Severity Symptom and the Health-related Quality of Life (HRQL). The Severity Symptom section included 6 questions. For each participant, the symptom severity score was derived as a sum of scores for Questions 1 to 6. The total score ranges from 6 to 36 with higher symptom severity score indicating greater symptom bother. OAB-q SF data obtained at week 0 visit were used as baseline.
Measured: Baseline and week 8, 16
Change From Baseline in OAB-q SF Total HRQL Score
The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Severity Symptom and the HRQL. The HRQL section included 13 questions. For each participant, the total HRQL score was derived as a sum of scores for Questions 7 to 19. The total score ranges from 13 to 78 with higher total HRQL score indicating greater HRQL. OAB-q SF data obtained at week 0 visit were used as baseline.
Measured: Baseline and week 8, 16
Change From Baseline in the Number of Micturitions Per 24 Hours
Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean number of micturitions per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urinated" was indicated, divided by the number of days on which episodes were recorded.
Measured: Baseline and week 4, 8, 12, 16
Number for Participants Who Achieved Normalization of the Number of Micturitions Per 24 Hours
Normalization for the mean number of micturitions per 24 hours was defined as < 8 micturitions per 24 hours.
Measured: Week 16
Change From Baseline in the Number of Urgency Episodes Per 24 Hours
Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urgency episode was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urgency" was indicated, divided by the number of days on which episodes were recorded. Only participants who had an urgency episode at baseline was included in the analysis.
Measured: Baseline and week 4, 8, 12, 16
Number for Participants Who Achieved Normalization of the Number of Urgency Episodes Per 24 Hours
Normalization for the mean number of urgency episodes per 24 hours was defined as no urgency episode per 24 hours.
Measured: Week 16
Change From Baseline in the Number of Incontinence Episodes Per 24 Hours
Participants completed the patient diary (paper document) for 3 days immediately before each visit. An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urinary incontinence'" was indicated, divided by the number of days on which episodes were recorded. Only participants who had an incontinence episode at baseline was included in the analysis.
Measured: Baseline and week 4, 8, 12, 16
Number for Participants Who Achieved Normalization of the Number of Incontinence Episodes Per 24 Hours
Normalization for the mean number of incontinence episodes per 24 hours was defined as no incontinence episode per 24 hours.
Measured: Week 16
Change From Baseline in the Number of Urge Incontinence Episodes Per 24 Hours
Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urge incontinence episode was defined as any episode when both urgency and incontinence occurred concurrently. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable "urgency" and "urinary incontinence'" were indicated, divided by the number of days on which episodes were recorded. Only participants who had an urge incontinence episode at baseline was included in the analysis.
Measured: Baseline and week 4, 8, 12, 16
Change From Baseline in the Volume Voided Per Micturition
Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean volume per micturition was calculated by taking the sum of the urinary volumes where the volume voided was > 0 and where "urinary incontinence" was not indicated in the patient diary, divided by the number of micturitions where the volume voided was > 0 and where "urinary incontinence" was not indicated. Only participants who had volume voided was > 0 at baseline was included in the analysis.
Measured: Baseline and week 8, 16
Change From Baseline in the Number of Nocturia Episodes Per Night
Participants completed the patient diary (paper document) for 3 days immediately before each visit. A nocturia episode was defined as waking at night 1 or more times to void. Night time was defined as the period between bedtime and the wake-up time the following day (micturitions at the same time as the wake-up time were excluded). The mean number of nocturia episodes per night was calculated by taking the sum of nocturia episodes in the patient diary where the variable "urinated" was indicated during the night time, divided by the number of nights. Only participants who had a nocturia episode at baseline was included in the analysis.
Measured: Baseline and week 4, 8, 12, 16
Change From Baseline in Postvoid Residual (PVR) Volume
Measurement of PVR volume was made using either ultrasonography or urethral catheterization, provided that the same method was used for the same participant throughout the study.
Measured: Baseline and week 4, 8, 12, 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2012 (estimated)
- Study start1 Oct 2012
- Primary completion23 Jul 2013
- Study completion23 Jul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overactive BladderStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745094
- Sponsor's protocol ID
- 178-CL-110
- Status last verified
- Dec 2017
- First submitted
- 6 Dec 2012
- Last updated
- 28 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Mirabegron as Add-on Therapy in Patients With Overactive Bladder Treated With Solifenacin: A Postmarketing Open-label Study in Japan
- ClinicalTrials.gov ID
- NCT01745094
- Acronym / sponsor ID
- 178-CL-110
- Conditions
- Overactive Bladder
- Keywords
- mirabegron, solifenacin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2012 (actual)
- Primary completion
- 23 Jul 2013 (actual)
- Study completion
- 23 Jul 2013 (actual)
- First posted
- 7 Dec 2012 (estimated)
- Results
- Posted 28 Feb 2018
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 was to evaluate the safety and efficacy of mirabegron as add-on therapy in patients with OAB treated with solifenacin.
Detailed description
The total duration of the study was 18 weeks, comprising a 2-week screening period and a 16-week treatment period. Patients meeting the eligibility criteria for provisional enrollment received the study drug for the screening period (solifenacin) at the same dose as that before the start of the study (2.5 or 5 mg), once daily after breakfast orally for 2 weeks. After the screening period, patients meeting the eligibility criteria for formal enrollment received the study drugs for the treatment period (solifenacin 2.5 or 5 mg and mirabegron 25 mg), once daily after breakfast orally for 16 weeks. Mirabegron dose could be increased to 50 mg at week 8 visit if the patients met all of the following criteria: (1) had an inadequate response to mirabegron at the dose of 25 mg; (2) was judged by the investigator or coinvestigator to have no safety concerns; and (3) agreed to increase the dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Concomitant Group | Experimental | Drug: mirabegron, Drug: solifenacinconcomitant administration of mirabegron to solifenacin treated patients |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female: postmenopausal OAB outpatient
- Male: OAB outpatient who did not wish to have children at all
- Patient had been treated with solifenacin at a stable dose once daily for at least 4 weeks prior to the study
- Patient had a total OAB symptom score (OABSS ) score of ≥3 points and a Question 3 score ≥2 points
Key exclusion criteria (3 listed)
- Patient had a residual urine volume of ≥100 mL or a maximum flow rate <5 mL/s, or patients with benign prostatic hyperplasia, or lower urinary tract obstruction
- Patient had serious heart disease (myocardial infarction, cardiac failure, uncontrolled angina pectoris, serious arrhythmia, use of pacemaker, etc.), liver disease, kidney disease, immunological disease, lung disease, etc. or patient had malignant tumor (except for malignant tumor that has not been treated for at least 5 y before the start of the screening period with no risk of recurrence)
- Patient had received surgical therapy that may affect the urinary tract function within 24 weeks before the start of the screening period
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 |
|---|---|---|
| mirabegronAlso: YM178, Betanisoral | Drug | Concomitant Group |
| solifenacinAlso: Vesicare, YM905oral | Drug | Concomitant Group |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose of study drug up to weeks 16
TEAEs were defined as AEs observed after the first administration of the study drugs for the treatment period. The investigator assessed the severity of AEs, including abnormal clinical laboratory values, Electrocardiogram (ECG), vital signs, as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. A drug-related TEAE was a TEAE with at least a possible relationship to the study drug as assessed by the investigator.
14 secondary outcomes
Change From Baseline in OABSS Total Score
Time frame: Baseline and week 8, 16
Number of Participants Who Achieved Normalization for OABSS Total Score
Time frame: Week 8 and 16
Change From Baseline in Overactive Bladder Questionnaire Short Form (OAB-q SF) Severity Score
Time frame: Baseline and week 8, 16
Change From Baseline in OAB-q SF Total HRQL Score
Time frame: Baseline and week 8, 16
Change From Baseline in the Number of Micturitions Per 24 Hours
Time frame: Baseline and week 4, 8, 12, 16
Number for Participants Who Achieved Normalization of the Number of Micturitions Per 24 Hours
Time frame: Week 16
Change From Baseline in the Number of Urgency Episodes Per 24 Hours
Time frame: Baseline and week 4, 8, 12, 16
Number for Participants Who Achieved Normalization of the Number of Urgency Episodes Per 24 Hours
Time frame: Week 16
Change From Baseline in the Number of Incontinence Episodes Per 24 Hours
Time frame: Baseline and week 4, 8, 12, 16
Number for Participants Who Achieved Normalization of the Number of Incontinence Episodes Per 24 Hours
Time frame: Week 16
Change From Baseline in the Number of Urge Incontinence Episodes Per 24 Hours
Time frame: Baseline and week 4, 8, 12, 16
Change From Baseline in the Volume Voided Per Micturition
Time frame: Baseline and week 8, 16
Change From Baseline in the Number of Nocturia Episodes Per Night
Time frame: Baseline and week 4, 8, 12, 16
Change From Baseline in Postvoid Residual (PVR) Volume
Time frame: Baseline and week 4, 8, 12, 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Director study director
Astellas Pharma Inc
5 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 mirabegron and solifenacin in people with Overactive Bladder, run by Astellas Pharma Inc at 5 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 3 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 28 Feb 2018. 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 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. 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?
Yes. Results are posted in the registry (first posted 28 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: From first dose of study drug up to weeks 16). 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 28 Feb 2018.