Study of ONO-8539 in Patients With Overactive Bladder

A Randomised, Multi-Centre, Double-Blind, Placebo and Active-Controlled, 5-Way Parallel Group Study to Investigate the Efficacy, Safety and Tolerability of ONO-8539 in Patients With Overactive Bladder

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00876421

Enrollment

435

Registered

2009-04-06

Start date

2009-04-30

Completion date

Unknown

Last updated

2012-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder

Keywords

ONO-8539, Overactive bladder, OAB

Brief summary

The objective of this study is to investigate efficacy, safety and tolerability of ONO-8539 in patients with overactive bladder.

Interventions

DRUGPlacebo

Placebo / 12 weeks

DRUGTolterodine

4mg / 12 weeks

DRUGONO-8539

low dose / 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Patients with medical history of Overactive Bladder symptoms for \> 6 months

Exclusion criteria

* Patients who have a history or presence of other significant diseases, which in the opinion of the investigator, might compromise the patient's safety or the evaluation of the study results

Design outcomes

Primary

Measure	Time frame
Overactive bladder symptoms	12 weeks

Secondary

Measure	Time frame
Overactive bladder symptoms (QOL)	12 weeks

Countries

Czechia, Germany, Hungary, Netherlands, Poland, Romania, Russia, Sweden, Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026