Clinical trial NCT01745094: A Study to Evaluate the Effect of Mirabegron + Solifenacin in Overactive Bladder Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overactive Bladder
Keywords: mirabegron
solifenacin
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2012-12-07
Enrollment: 223
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From first dose of study drug up to weeks 16
Secondary outcomes:
measure: Change From Baseline in OABSS Total Score
timeFrame: Baseline and week 8, 16
measure: Number of Participants Who Achieved Normalization for OABSS Total Score
timeFrame: Week 8 and 16
measure: Change From Baseline in Overactive Bladder Questionnaire Short Form (OAB-q SF) Severity Score
timeFrame: Baseline and week 8, 16
measure: Change From Baseline in OAB-q SF Total HRQL Score
timeFrame: Baseline and week 8, 16
measure: Change From Baseline in the Number of Micturitions Per 24 Hours
timeFrame: Baseline and week 4, 8, 12, 16
measure: Number for Participants Who Achieved Normalization of the Number of Micturitions Per 24 Hours
timeFrame: Week 16
measure: Change From Baseline in the Number of Urgency Episodes Per 24 Hours
timeFrame: Baseline and week 4, 8, 12, 16
measure: Number for Participants Who Achieved Normalization of the Number of Urgency Episodes Per 24 Hours
timeFrame: Week 16
measure: Change From Baseline in the Number of Incontinence Episodes Per 24 Hours
timeFrame: Baseline and week 4, 8, 12, 16
measure: Number for Participants Who Achieved Normalization of the Number of Incontinence Episodes Per 24 Hours
timeFrame: Week 16
measure: Change From Baseline in the Number of Urge Incontinence Episodes Per 24 Hours
timeFrame: Baseline and week 4, 8, 12, 16
measure: Change From Baseline in the Volume Voided Per Micturition
timeFrame: Baseline and week 8, 16
measure: Change From Baseline in the Number of Nocturia Episodes Per Night
timeFrame: Baseline and week 4, 8, 12, 16
measure: Change From Baseline in Postvoid Residual (PVR) Volume
timeFrame: Baseline and week 4, 8, 12, 16
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyushu
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References: