Clinical trial NCT01908829
Conditions: Urinary Bladder Diseases Urinary Bladder Overactive Urologic Diseases
Keywords: Vesitrim Betanis Urgency Frequency Mirabegron YM178 Betmiga Vesicare Micturition YM905 Solifenacin Urinary incontinence Overactive Bladder (OAB) Myrbetriq Vesikur Urgency incontinence
Sponsor: Astellas Pharma Europe Ltd.
Start date: 2013-07-10; Completion date: 2014-11-25
Enrollment: 2174 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to see if adding a new type of medication recently approved to treat overactive bladder (mirabegron) to an antimuscarinic treatment (solifenacin) would be more effective in controlling incontinence than when using the antimuscarinic treatment alone.

Detailed description:

Arms: arm 1: Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period. arm 2: Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period arm 3: Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Interventions: intervention 1: mirabegron 25 mg intervention 2: mirabegron 50 mg intervention 3: solifenacin 5 mg intervention 4: solifenacin 10 mg intervention 5: mirabegron 25 mg matching placebo intervention 6: mirabegron 50 mg matching placebo intervention 7: solifenacin 5 mg matching placebo intervention 8: solifenacin 10 mg matching placebo
Intervention descriptions: intervention 1: Mirabegron was supplied as the marketed formulation in the 25 mg OCAS (Oral Controlled Absorption System) modified release tablets. Medication was taken orally with a glass of water, with or without food. intervention 2: Mirabegron was supplied as the marketed formulation in the 50 mg OCAS (Oral Controlled Absorption System) modified release tablets. Medication was taken orally with a glass of water, with or without food. intervention 3: Solifenacin was provided as the marketed formulation in the 5 mg strength. Medication was taken orally with a glass of water, with or without food. intervention 4: Solifenacin was provided as the marketed formulation in the 10 mg strength. Medication was taken orally with a glass of water, with or without food. intervention 5: Matching placebo of mirabegron OCAS 25 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food. intervention 6: Matching placebo of mirabegron OCAS 50 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food. intervention 7: Matching placebo of solifenacin succinate 5 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food. intervention 8: Matching placebo of solifenacin succinate 10 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.

Protocol documents: