Overactive Bladder (OAB)Phase 4NCT02294396
Postmarketing Study to Evaluate add-on Therapy With Anticholinergics in Patients With Overactive Bladder (OAB) on Mirabegron.
A Phase 4 study testing Mirabegron tablet, Solifenacin tablet and Propiverine tablet in people with Overactive Bladder (OAB), run by Astellas Pharma Inc at 7 sites in Japan.
Trial summary
The objective of the study was to evaluate the safety and efficacy of add-on therapy with anticholinergics in patients with OAB on mirabegron. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Overactive Bladder (OAB)
- What is being tested?
- Mirabegron tablet, Solifenacin tablet and Propiverine tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 649 participants
- Where
- 7 sitesJapan
- Study dates
- 28 Oct 2014to 7 Sep 2016
- 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: OAB outpatient who had been postmenopausal for at least 1 year
- Male: OAB outpatient who had no wish to have children in the future
- Patient had been under treatment with mirabegron at a stable dose of 50 mg once daily for at least 6 weeks before the start of the screening period
- Patient capable of walking to the bathroom without assistance
- Patient had a total Overactive Bladder Symptom Score (OABSS) of ≥3 points and a Question 3 score of ≥2 points
Who cannot join
- Patient had an established diagnosis of stress urinary incontinence (patient had no symptom other than stress urinary incontinence)
- Patient had urinary tract infection (cystitis, prostatitis, etc.), urinary calculus (ureteric calculus, urethral calculus, bladder calculus, etc.), interstitial cystitis, or a history of recurrent urinary tract infection (at least 3 episodes within 24 weeks before the start of the screening period)
- Patient had a residual urine volume of ≥100 mL at week -2 visit or patient with benign prostatic hyperplasia or lower urinary tract obstruction
- Patient had uncontrolled hypertension (sitting systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg at week -2 visit)
- Patient had a pulse rate of ≥110 bpm or <50 bpm at week -2 visit
- Patient had a contraindication to antimuscarinics (urinary retention; obstruction in thepylorus, duodenum, or intestine; paralytic ileus; gastric/intestinal atony; myasthenia gravis; and decreased gastrointestinal motility/tone, etc.)
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- Patient had glaucoma, ulcerative colitis, hyperthyroidism, dementia, cognitive dysfunction, parkinsonism symptoms, or clinically significant cerebrovascular disorder
- 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 a history of malignant tumor (except for malignant tumor that had not been treated for at least 5 years before the start of the screening period with no risk of recurrence)
- Patient had drug hypersensitivity to β-agonists or anticholinergics
- Patient was under treatment with flecainide acetate or propafenone hydrochloride
- Patient had long QT syndrome, patient was vulnerable to arrhythmia such as bradycardia or acute myocardial ischemia, patient had hypokalemia, and patient had ischemic heart disease such as angina pectoris
- Patient had used any prohibited concomitant medication within 4 weeks before the start of the screening period
- Patient was under catheterization or intermittent self-catheterization or patient had pelvic organ prolapse that affected the urinary tract function
- Patient had received radiotherapy that affected the urinary tract function
- Patient had received surgical therapy that may have affected the urinary tract function within 24 weeks before the start of the screening period
- Patient had received nonpharmacological therapy for OAB such as electric stimulation therapy (interferential low frequency therapy, magnetic stimulation therapy, etc.), biofeedback therapy, bladder training, or pelvic floor muscle exercise within 2 weeks before the start of the screening period
- Patient had or had a history of mood disorder, neurotic disorder, and schizophrenia
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
Study site
Chūbu
Study site
Chugoku
Study site
Hokkaido
Study site
Kansai
Study site
Kantou
Study site
Kyushu
Study site
Tōhoku
About this study
Official title: Postmarketing Study of Mirabegron in Japan: Long-term Add-on Therapy With Antimuscarinics in Patients With Overactive Bladder Treated With Mirabegron
The objective of the study was to evaluate the safety and efficacy of add-on therapy with anticholinergics in patients with OAB on mirabegron.
Read the detailed description
This was a multicenter, open-label study to evaluate the safety and efficacy of add-on therapy with antimuscarinics in patients with OAB treated with mirabegron.
The total duration of the study period was 54 weeks in total, comprising a 2-week screening period and a 52-week treatment period. Patients who met the eligibility criteria for provisional enrollment received orally the study drug for the screening period (mirabegron 50 mg) once daily after breakfast for 2 weeks. Patients who met the eligibility criteria after the screening period were randomized to solifenacin 5 mg, propiverine 20 mg, imidafenacin 0.2 mg or tolterodine 4 mg in a 1:1:1:1 ratio, and received orally mirabegron 50 mg and antimuscarinics for 52 weeks. At week 8 visit, the dose of all antimuscarinics except for tolterodine could be increased by 2-fold (solifenacin 10 mg, propiverine 40 mg or imidafenacin 0.4 mg) if a patient met the following criteria: (1) had no response to the study drugs; (2) was considered by the investigator to have no safety concerns; and (3) agreed to increase the dose. However, in the event of AEs after the dose was increased, it could be reduced to the level before the increase. A dose increase for a second time after dose reduction was not permitted.
- Conditions
- Overactive Bladder (OAB)
- Being tested
- Mirabegron tablet, Solifenacin tablet, Propiverine tablet, Imidafenacin tablet, Tolterodine capsule
- Keywords
- Anticholinergic, Overactive Bladder (OAB), Mirabegron, YM178
- 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.
Mirabegron tabletDrug
Also called YM178
orally administered at a dose of 1 tablet once daily after breakfast
Solifenacin tabletDrug
orally administered at a dose of 1 tablet once daily after breakfast (could be increased to 2 tablets)
Propiverine tabletDrug
orally administered at a dose of 1 tablet once daily after breakfast (could be increased to 1 tablet twice daily after breakfast and after dinner)
Imidafenacin tabletDrug
orally administered at a dose of 1 tablet (0.1 mg tablet) twice daily after breakfast and after dinner (could be increased to 2 tablets twice daily after breakfast and after dinner)
Tolterodine capsuleDrug
orally administered at a dose of 1 capsule once daily after breakfast (could not be increased)
| Study group | Role | What they receive |
|---|---|---|
| Mirabegron + Solifenacin | Experimental | Participants received mirabegron 50 mg and solifenacin 5 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of solifenacin 10 mg, if the treatment was not effective. Receives: Drug: Mirabegron tablet; Drug: Solifenacin tablet |
| Mirabegron + Propiverine | Experimental | Participants received mirabegron 50 mg and propiverine 20 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of propiverine 40 mg, if the treatment was not effective. Receives: Drug: Mirabegron tablet; Drug: Propiverine tablet |
| Mirabegron + Imidafenacin | Experimental | Participants received mirabegron 50 mg and imidafenacin 0.2 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of imidafenacin 0.4 mg, if the treatment was not effective. Receives: Drug: Mirabegron tablet; Drug: Imidafenacin tablet |
| Mirabegron + Tolterodine | Experimental | Participants received mirabegron 50 mg and tolterodine 4 mg once daily after breakfast orally for 52 weeks. Receives: Drug: Mirabegron tablet; Drug: Tolterodine capsule |
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 week 52
Secondary outcomes (15)
Change From Baseline in Overactive Bladder Symptom Score (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 4, 8, 12, 16, 28 and 52
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 52 (end of treatment)
Change From Baseline in Overactive Bladder Questionnaire Short Form (OAB-q SF) Symptom Severity Score
The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Symptom Severity and the Health-related Quality of Life (HRQL). The Symptom Severity 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 12, 28 and 52
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 12, 28 and 52
Change From Baseline in the Mean 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, 28, 40, 52
Number for Participants Who Achieved Normalization of the Mean 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 52 (end of treatment)
Change From Baseline in the Mean 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, 28, 40, 52
Number for Participants Who Achieved Normalization of the Mean 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 52 (end of treatment)
Change From Baseline in the Mean 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, 28, 40, 52
Number for Participants Who Achieved Normalization of the Mean 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 52 (end of treatment)
Change From Baseline in the Mean 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, 28, 40, 52
Change From Baseline in the Mean 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 4, 8, 12, 16, 28, 40, 52
Change From Baseline in the Mean 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, 28, 40, 52
Number of Participants Who Achieved Normalization of the Mean Number of Nocturia Episodes Per 24 Hours
Normalization for the mean number of nocturia episodes per 24 hours was defined as no nocturia episode per 24 hours.
Measured: Week 52 (end of treatment)
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, 20, 24, 28, 32, 36, 40, 44, 48, 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study start28 Oct 2014
- Primary completion7 Sep 2016
- Study completion7 Sep 2016
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 Bladder (OAB)Studies 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
- None (open label)
- Enrolment
- 649 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
- NCT02294396
- Sponsor's protocol ID
- 178-CL-112
- Status last verified
- Oct 2024
- First submitted
- 10 Nov 2014
- Last updated
- 31 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postmarketing Study of Mirabegron in Japan: Long-term Add-on Therapy With Antimuscarinics in Patients With Overactive Bladder Treated With Mirabegron
- ClinicalTrials.gov ID
- NCT02294396
- Acronym / sponsor ID
- 178-CL-112
- Conditions
- Overactive Bladder (OAB)
- Keywords
- Anticholinergic, Overactive Bladder (OAB), Mirabegron, YM178
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 649 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2014 (actual)
- Primary completion
- 7 Sep 2016 (actual)
- Study completion
- 7 Sep 2016 (actual)
- First posted
- 19 Nov 2014 (estimated)
- Results
- Posted 24 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study was to evaluate the safety and efficacy of add-on therapy with anticholinergics in patients with OAB on mirabegron.
Detailed description
This was a multicenter, open-label study to evaluate the safety and efficacy of add-on therapy with antimuscarinics in patients with OAB treated with mirabegron.
The total duration of the study period was 54 weeks in total, comprising a 2-week screening period and a 52-week treatment period. Patients who met the eligibility criteria for provisional enrollment received orally the study drug for the screening period (mirabegron 50 mg) once daily after breakfast for 2 weeks. Patients who met the eligibility criteria after the screening period were randomized to solifenacin 5 mg, propiverine 20 mg, imidafenacin 0.2 mg or tolterodine 4 mg in a 1:1:1:1 ratio, and received orally mirabegron 50 mg and antimuscarinics for 52 weeks. At week 8 visit, the dose of all antimuscarinics except for tolterodine could be increased by 2-fold (solifenacin 10 mg, propiverine 40 mg or imidafenacin 0.4 mg) if a patient met the following criteria: (1) had no response to the study drugs; (2) was considered by the investigator to have no safety concerns; and (3) agreed to increase the dose. However, in the event of AEs after the dose was increased, it could be reduced to the level before the increase. A dose increase for a second time after dose reduction was not permitted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mirabegron + Solifenacin | Experimental | Drug: Mirabegron tablet, Drug: Solifenacin tabletParticipants received mirabegron 50 mg and solifenacin 5 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of solifenacin 10 mg, if the treatment was not effective. |
| Mirabegron + Propiverine | Experimental | Drug: Mirabegron tablet, Drug: Propiverine tabletParticipants received mirabegron 50 mg and propiverine 20 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of propiverine 40 mg, if the treatment was not effective. |
| Mirabegron + Imidafenacin | Experimental | Drug: Mirabegron tablet, Drug: Imidafenacin tabletParticipants received mirabegron 50 mg and imidafenacin 0.2 mg once daily after breakfast orally for 8 weeks. In the next 44 weeks, participants continued to receive mirabegron 50 mg, but received an increased dose of imidafenacin 0.4 mg, if the treatment was not effective. |
| Mirabegron + Tolterodine | Experimental | Drug: Mirabegron tablet, Drug: Tolterodine capsuleParticipants received mirabegron 50 mg and tolterodine 4 mg once daily after breakfast orally for 52 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female: OAB outpatient who had been postmenopausal for at least 1 year
- Male: OAB outpatient who had no wish to have children in the future
- Patient had been under treatment with mirabegron at a stable dose of 50 mg once daily for at least 6 weeks before the start of the screening period
- Patient capable of walking to the bathroom without assistance
- Patient had a total Overactive Bladder Symptom Score (OABSS) of ≥3 points and a Question 3 score of ≥2 points
Key exclusion criteria (17 listed)
- Patient had an established diagnosis of stress urinary incontinence (patient had no symptom other than stress urinary incontinence)
- Patient had urinary tract infection (cystitis, prostatitis, etc.), urinary calculus (ureteric calculus, urethral calculus, bladder calculus, etc.), interstitial cystitis, or a history of recurrent urinary tract infection (at least 3 episodes within 24 weeks before the start of the screening period)
- Patient had a residual urine volume of ≥100 mL at week -2 visit or patient with benign prostatic hyperplasia or lower urinary tract obstruction
- Patient had uncontrolled hypertension (sitting systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg at week -2 visit)
- Patient had a pulse rate of ≥110 bpm or <50 bpm at week -2 visit
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 |
|---|---|---|
| Mirabegron tabletAlso: YM178orally administered at a dose of 1 tablet once daily after breakfast | Drug | Mirabegron + Imidafenacin, Mirabegron + Propiverine, Mirabegron + Solifenacin, Mirabegron + Tolterodine |
| Solifenacin tabletorally administered at a dose of 1 tablet once daily after breakfast (could be increased to 2 tablets) | Drug | Mirabegron + Solifenacin |
| Propiverine tabletorally administered at a dose of 1 tablet once daily after breakfast (could be increased to 1 tablet twice daily after breakfast and after dinner) | Drug | Mirabegron + Propiverine |
| Imidafenacin tabletorally administered at a dose of 1 tablet (0.1 mg tablet) twice daily after breakfast and after dinner (could be increased to 2 tablets twice daily after breakfast and after dinner) | Drug | Mirabegron + Imidafenacin |
| Tolterodine capsuleorally administered at a dose of 1 capsule once daily after breakfast (could not be increased) | Drug | Mirabegron + Tolterodine |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose of study drug up to week 52
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.
15 secondary outcomes
Change From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score
Time frame: Baseline and week 4, 8, 12, 16, 28 and 52
Number of Participants Who Achieved Normalization for OABSS Total Score
Time frame: Week 52 (end of treatment)
Change From Baseline in Overactive Bladder Questionnaire Short Form (OAB-q SF) Symptom Severity Score
Time frame: Baseline and week 12, 28 and 52
Change From Baseline in OAB-q SF Total HRQL Score
Time frame: Baseline and week 12, 28 and 52
Change From Baseline in the Mean Number of Micturitions Per 24 Hours
Time frame: Baseline and week 4, 8, 12, 16, 28, 40, 52
Number for Participants Who Achieved Normalization of the Mean Number of Micturitions Per 24 Hours
Time frame: Week 52 (end of treatment)
Change From Baseline in the Mean Number of Urgency Episodes Per 24 Hours
Time frame: Baseline and week 4, 8, 12, 16, 28, 40, 52
Number for Participants Who Achieved Normalization of the Mean Number of Urgency Episodes Per 24 Hours
Time frame: Week 52 (end of treatment)
Change From Baseline in the Mean Number of Incontinence Episodes Per 24 Hours
Time frame: Baseline and week 4, 8, 12, 16, 28, 40, 52
Number for Participants Who Achieved Normalization of the Mean Number of Incontinence Episodes Per 24 Hours
Time frame: Week 52 (end of treatment)
Change From Baseline in the Mean Number of Urge Incontinence Episodes Per 24 Hours
Time frame: Baseline and week 4, 8, 12, 16, 28, 40, 52
Change From Baseline in the Mean Volume Voided Per Micturition
Time frame: Baseline and week 4, 8, 12, 16, 28, 40, 52
Change From Baseline in the Mean Number of Nocturia Episodes Per Night
Time frame: Baseline and week 4, 8, 12, 16, 28, 40, 52
Number of Participants Who Achieved Normalization of the Mean Number of Nocturia Episodes Per 24 Hours
Time frame: Week 52 (end of treatment)
Change From Baseline in Postvoid Residual (PVR) Volume
Time frame: Baseline and week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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
7 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 tablet, Solifenacin tablet and Propiverine tablet in people with Overactive Bladder (OAB), run by Astellas Pharma Inc at 7 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 5 inclusion and 17 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 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 24 Dec 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 week 52). 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 31 Oct 2024.