Overview

This trial has been completed.

Conditions urinary bladder overactive, overactive bladder, urgency incontinence, urinary bladder diseases\urologic diseases
Treatments solifenacin succinate, mirabegron
Phase phase 3
Sponsor Astellas Pharma Europe B.V.
Start date March 2014
End date September 2016
Trial size 2084 participants
Trial identifier NCT02045862, 178-CL-102, 2012-005736-29

Summary

The purpose of this study is to examine how well the combination of two medicines (solifenacin succinate and mirabegron) work compared to each medicine alone in the treatment of bladder problems, and how safe they are for long term use.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
oral
solifenacin succinate Vesicare
oral
mirabegron Myrbetriq
oral
(Active Comparator)
oral
solifenacin succinate Vesicare
oral
(Active Comparator)
oral
mirabegron Myrbetriq
oral

Primary Outcomes

Measure
Incidence and severity of treatment emergent adverse events (TEAEs)
time frame: 12 Months
Change from baseline in mean number of incontinence episodes per 24 hours at EoT
time frame: Baseline and 12 Months
Change from baseline in mean number of micturitions per 24 hours at EoT
time frame: Baseline and 12 Months

Secondary Outcomes

Measure
Vital signs: sitting systolic and diastolic blood pressure and pulse rate (home measurements and office measurements)
time frame: 12 Months
Laboratory tests: hematology, biochemistry, and urinalysis
time frame: 12 Months
Electrocardiogram (ECG) parameters
time frame: 12 Months
Post-void residual volume (PVR)
time frame: 12 Months
Change from baseline in mean volume voided per micturition at EoT
time frame: Baseline and 12 Months
Change from baseline in Symptom Bother as assessed by Overactive Bladder Questionnaire (OAB-q) at EoT
time frame: Baseline and 12 Months
Change from baseline in subject assessment of Treatment Satisfaction-Visual Analogue Scale (TS-VAS) at EoT
time frame: Baseline and 12 Months
Number of incontinence episodes at Month 1, 3, 6, 9, 12 and EoT and changes from baseline
time frame: Baseline and 12 months
Change from baseline in mean number of incontinence episodes at secondary time points (after 1, 3, 6, 9 and 12) Months of treatment
time frame: Baseline and 12 Months
Change from baseline in mean number of micturitions at secondary time points (after 1, 3, 6, 9 and 12 Months of treatment)
time frame: Baseline and 12 Months
Change from baseline in mean volume voided at secondary time points (after 1, 3, 6, 9 and 12 Months of treatment)
time frame: Baseline and 12 Months
Number of urgency incontinence episodes during the 7-day observation period prior to Month 1, 3, 6, 9, 12 and EoT and changes from baseline
time frame: Baseline and 12 Months
Change from baseline in mean number of urgency incontinence episodes per 24 hours (Month 1, 3, 6, 9, 12 and EoT)
time frame: Baseline and 12 months
Change from baseline in mean number of urgency episodes (grade 3 and/or 4)/24 hours (Patient Perception of Intensity of Urgency Scale (PPIUS scale)) (Month 1, 3, 6, 9, 12 and EoT)
time frame: Baseline and 12 months
Number of nocturia episodes during the 7-day observation period prior to Month 1, 3, 6, 9, 12 and EoT and changes from baseline
time frame: Baseline and 12 months
Change from baseline in mean number of nocturia episodes per 24 hours (Month 1, 3, 6, 9, 12 and EoT)
time frame: Baseline and 12 months
Number of pads used during the 7-day observation period prior to Month 1, 3, 6, 9, 12, and EoT and changes from baseline
time frame: Baseline and 12 Months
Change from baseline in mean number of pads used per 24 hours (Month 1, 3, 6, 9, 12, and EoT)
time frame: Baseline and 12 Months
Number of incontinence-free days during the 7-day diary period (Month 1, 3, 6, 9, 12 and EoT)
time frame: 12 Months
Number of days with less than 8 micturitions during the 7-day diary period (Month 1, 3, 6, 9, 12 and EoT)
time frame: 12 Months
Number of incontinence-free days with less than 8 micturitions per day during the 7-day diary period (Month 1, 3, 6, 9, 12 and EoT)
time frame: 12 Months
Change from baseline in Patient Perception of Bladder Condition (PPBC) (Month 1, 3, 6, 9, and 12)
time frame: Baseline and 12 Months
Change from baseline in Symptom Bother as assessed by the OAB-q at secondary time points (Month 1, 3, 6, 9, 12 and EoT)
time frame: Baseline and 12 Months
Change from baseline in health related QoL scores as assessed by the OAB-q (including subscales) (Month 1, 3, 6, 9, 12 and EoT)
time frame: Baseline and 12 Months
Patient Global Impression of Change (PGIC) scale (Month 12 and EoT)
time frame: 12 Months
Change from baseline in scores as assessed by the European Quality of Life in 5 Dimensions (EQ-5D0 questionnaire (including subscales) (Month 1, 3, 6, 9, 12 and EoT)
time frame: Baseline and 12 Months
Change from baseline in scores as assessed by the Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire (Month 6,12 and EoT)
time frame: Baseline and 12 Months
Change from baseline in the subject's assessment of TS-VAS at secondary time points (Month 1, 3, 6, 9, and 12)
time frame: Baseline and 12 Months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: Main Inclusion at Screening (Visit 1): - Subject has completed study 178-CL-101 or study 905-EC-012 (This inclusion criterion will no longer apply once the recruitment for study 178-CL-101 and study 905-EC-012 has been completed. In that case the subject has to have symptoms of "wet" OAB (urinary frequency and urgency with incontinence) for at least 3 months); - Subject is willing and able to complete the micturition diary and questionnaires correctly and able to measure his/her vital signs at home at stipulated time points, using the device provided by the study personnel, and to adequately record the readings; Main Inclusion at Randomization (Visit 2): - Subject has a micturition frequency of on average ≥ 8 times per 24-hour period during the last 7 days of the micturition diary period (incontinence episode should not be counted as a micturition). - Subject has experienced at least 3 incontinence episodes during the last 7 days of the micturition diary period. - Subject has experienced on average at least 1 urgency episode (grade 3 or 4 on Patient Perception of Intensity of Urgency Scale [PPIUS]) per 24-hour period during the 7-day micturition diary period. Exclusion Criteria: Main Exclusion at Screening (Visit 1): - Subject has clinically significant bladder outflow obstruction at risk of urinary retention; - Subject has significant PVR volume (> 150 mL); - Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor; - Subject has an indwelling catheter or practices intermittent self-catheterization; - Subject has evidence of a UTI (urine culture containing > 100,000 cfu/mL), chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs; - Subject has had intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin; Main Exclusion at Randomization (Visit 2): - Subject has evidence of a UTI (urine culture containing > 100,000 cfu/mL) as assessed in the Screening visit (V1) samples. The subject can be rescreened after successful treatment of the UTI (confirmed by a dipstick negative for nitrite). - Subject had an average total daily urine volume > 3000 mL as recorded in the micturition diary period.

Additional Information

Official title A Randomized, Double-Blind, Parallel-Group, Active-Controlled, Multi-center Study to Evaluate the Long-Term Safety and Efficacy of Combination of Solifenacin Succinate With Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in Subjects With Overactive Bladder
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Astellas Pharma Inc.