Study of ONO-8577 in Patients With Overactive Bladder

Ono Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Overactive Bladder

Treatments: Drug: solifenacin succinate + mirabegron; Drug: Placebo; Drug: ONO-8577

Study type: Interventional

Funder types: Industry

Identifiers

NCT03106623

ONO-8577-02

Details and patient eligibility

About

The objective of the study is to evaluate the efficacy and safety of ONO-8577 compared to combination of solifenacin succinate and mirabegron or placebo for overactive bladder

Enrollment: 207 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with symptoms of overactive bladder for ≥6 months

Exclusion criteria

• Patient with genuine stress incontinence, or with stress-predominant mixed urinary incontinence
• Patient who has never experienced urge urinary incontinence during disease duration of overactive bladder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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207 participants in 3 patient groups, including a placebo group

ONO-8577 Arm

Experimental group

Description:

Oral administration of ONO-8577 once a daily for 4 weeks

Treatment:

Drug: ONO-8577

Active Comparator Arm

Active Comparator group

Description:

Oral administration of solifenacin succinate and mirabegron once a daily for 4 weeks

Treatment:

Drug: solifenacin succinate + mirabegron

Placebo Arm

Placebo Comparator group

Description:

Oral administration of Placebo once a daily for 4 weeks

Treatment:

Drug: Placebo