Phase 2a Exploratory, Randomized, Double-blind, Parallel-group Study of ONO-8577 Compared to Combination of Solifenacin Succinate/ Mirabegron for Overactive Bladder

Ono Pharmaceutical Co. Ltd30 sites in 1 country207 target enrollmentApril 7, 2017

ConditionsOveractive Bladder

InterventionsONO-8577 solifenacin succinate + mirabegron Placebo

DrugsONO-8577 solifenacin succinate + mirabegron Placebo

Overview

Phase: Phase 2
Intervention: ONO-8577
Conditions: Overactive Bladder
Sponsor: Ono Pharmaceutical Co. Ltd
Enrollment: 207
Locations: 30
Primary Endpoint: Efficacy (Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

April 7, 2017

End Date

September 26, 2017

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ono Pharmaceutical Co. Ltd

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

ONO-8577 Arm

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

Intervention: ONO-8577

Active Comparator Arm

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

Intervention: solifenacin succinate + mirabegron

Placebo Arm

Oral administration of Placebo once a daily for 4 weeks

Intervention: Placebo

Outcomes

Primary Outcomes

Efficacy (Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours)

Time Frame: Baseline and Week 4

Secondary Outcomes

Efficacy (Change From Baseline to Week 2 in Mean Number of Micturitions Per 24 Hours)(Baseline and Week 2)
Efficacy (Change From Baseline to Week 4 in Health-related Quality of Life)(Baseline and Week 4)
Efficacy (Patient Global Impression at Week 4)(Week 4)
Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Volume Voided Per Micturition)(Baseline, Week 2 and 4)
Pharmacokinetics (plasma concentration at one point on each visit)(Week 2 and 4)
Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Micturitions Per 24 Hours)(Baseline, Week 2 and 4)
Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Incontinence Episodes Per 24 Hours)(Baseline, Week 2 and 4)
Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Urgency Incontinence Episodes Per 24 Hours)(Baseline, Week 2 and 4)
Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Nocturia Episodes Per 24 Hours)(Baseline, Week 2 and 4)
Efficacy (Percentage of Participants With Zero Incontinence Episodes at Week 2 and 4(Week 2 and 4)
Efficacy (Change From Baseline to Week 2 and 4 in Overactive Bladder Symptom Score (OABSS) )(Baseline, Week 2 and 4)
Safety (adverse event, vital signs, 12-lead electrocardiography, residual urine volume, clinical laboratory test)(Up to Week 4)
Efficacy (Change and Change Rate From Baseline to Week 2 and 4 in Mean Number of Urgency Episodes Per 24 Hours)(Baseline, Week 2 and 4)
Efficacy (Percentage of Participants With ˂8 times of Micturitions Per 24 Hours at Week 2 and 4)(Week 2 and 4)