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

Completed · Phase 3 · Has a placebo group

Conditions studied: Urinary Bladder Overactive, Overactive Bladder, Urgency Incontinence, Urinary Bladder Diseases\Urologic Diseases

In brief

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.

Key facts

Study ID: NCT02045862
Run by: Astellas Pharma Europe B.V.
People needed: 1829
Starts: 2014-03-17
Expected to finish: 2016-09-08
Last updated by the study team: 2024-10-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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 where stress is the predominant factor;
Subject has an indwelling catheter or practices intermittent self-catheterization;
Subject had 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 had intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin;
Main Exclusion at Randomization (Visit 2):
Subject had evidence of a urinary tract infection (UTI) (urine culture containing > 100,000 cfu/mL) as assessed in the Screening visit (V1) samples. The subject could 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.

Where it is running

Site US10112 — Mobile, Alabama, United States
Site US10104 — Chandler, Arizona, United States
Site US10021 — Phoenix, Arizona, United States
Site US10122 — Anaheim, California, United States
Site US10082 — Hawaiian Gardens, California, United States
Site US10132 — Los Angeles, California, United States
Site US10133 — Los Angeles, California, United States
Site US10149 — Paramount, California, United States
Site US10003 — San Diego, California, United States
Site US10106 — Tarzana, California, United States
Site US10595 — Valley Village, California, United States
Site US10053 — Wheat Ridge, Colorado, United States
Site US10060 — Bradenton, Florida, United States
Site US10097 — Hialeah, Florida, United States
Site US10148 — Hialeah, Florida, United States
Site US10153 — Hialeah, Florida, United States
Site US10091 — Jupiter, Florida, United States
Site US10150 — New Port Richey, Florida, United States
Site US10124 — Orlando, Florida, United States
Site US10134 — Orlando, Florida, United States
Site US10009 — Pembroke Pines, Florida, United States
Site US10554 — Plantation, Florida, United States
Site US10037 — Alpharetta, Georgia, United States
Site US10127 — Roswell, Georgia, United States
Site US10049 — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.