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Long-term Safety and Efficacy of Imidafenacin in Patients With Overactive Bladder

An Open-label Study to Evaluate the Long-term Safety and Efficacy of Imidafenacin in Patients With Overactive Bladder

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00512785
Enrollment
435
Registered
2007-08-08
Start date
2007-08-31
Completion date
Unknown
Last updated
2012-06-13

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

Conditions

Overactive Bladder

Keywords

Imidafenacin, KRP-197/ONO-8025, overactive bladder, antimuscarinic

Brief summary

The purpose of this study is to evaluate the long-term safety and efficacy of imidafenacin.

Interventions

DRUGimidafenacin, KRP-197/ONO-8025

0.1 mg BID for 52 weeks

Sponsors

Kyorin Pharmaceutical Co.,Ltd
CollaboratorINDUSTRY
Ono Pharmaceutical Co. Ltd
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Men and Woman equal or \> 20 years old * Patients with urgency, urinary frequency and urgency incontinence

Exclusion criteria

* Patients with genuine stress incontinence * Patients suffering from complications such as bladder tumor, urinary tract stone and symptomatic urinary tract infection * Patients suffering from complications contraindicating the use of antimuscarinic medication * Patients with polyuria

Design outcomes

Primary

MeasureTime frame
Safety Measures: adverse events, laboratory tests, 12-lead ECG, vital signs, post-void residual volume64 weeks

Secondary

MeasureTime frame
Efficacy measures: number of urgency incontinence episodes per week, number of incontinence episodes per week, number of micturitions per day, number of urgency episodes per day, severity of urgency, urine volume voided per micturition, Quality of Life64 weeks

Countries

Japan

Outcome results

None listed

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