A Multinational Study Comparing the Long-term Efficacy and Safety of Two Medicines, Solifenacin S… (NCT02045862) | Clinical Trial Compass
CompletedPhase 3
A Multinational Study Comparing the Long-term Efficacy and Safety of Two Medicines, Solifenacin Succinate and Mirabegron Taken Together, or Separately, in Subjects With Symptoms of Overactive Bladder
United States1,829 participantsStarted 2014-03-17
Plain-language summary
The purpose of this study was to examine how well the combination of two medicines (solifenacin succinate and mirabegron) worked compared to each medicine alone in the treatment of bladder problems, and how safe they were for long term use.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Main Inclusion at Screening (Visit 1):
* Subject had completed study 178-CL-101 or study 905-EC-012 (This inclusion criterion would no longer apply once the recruitment for study 178-CL-101 and study 905-EC-012 had been completed. In that case the subject had to have symptoms of "wet" OAB (urinary frequency and urgency with incontinence) for at least 3 months);
* Subject was 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 had 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 had experienced at least 3 incontinence episodes during the last 7 days of the micturition diary period.
* Subject had 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 had clinically significant bladder outflow obstruction at risk of urinary retention;
* Subject had significant PVR volume (\> 150 mL);
* Subject had significant stress incontinence or mixed stress/urgency incontinence wher…
What they're measuring
1
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Timeframe: From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 56 weeks)
2
Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours
Timeframe: Baseline and Week 52
3
Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours