A Confirmatory Study of KUC-7483 in Patients With Overactive Bladder

A Randomized, Double Blind, Placebo Controlled, Phase III Study of KUC-7483 in Patients With Overactive Bladder

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01004315

Enrollment

750

Registered

2009-10-29

Start date

Unknown

Completion date

Unknown

Last updated

2010-07-27

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

Conditions

Overactive Bladder

Keywords

Overactive bladder, Frequency, Micturition, Urgency, Urge urinary incontinence, OAB

Brief summary

To evaluate the efficacy and the safety of KUC-7483 in overactive bladder patients.

Interventions

DRUGKUC-7483

DRUGPlacebo

DRUGTolterodine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with a symptom of overactive bladder for more than 6 months. * Patients who meet the following condition during the 3-day bladder diary period. * the mean number of micturitions per 24 hours is ≥8 times * the mean number of urgency episodes per 24 hours is ≥1 time

Exclusion criteria

* Patients who are diagnosed as stress urinary incontinence are predominant. * Patients with urinary calculus, interstitial cystitis, or clinically significant urinary tract infection.

Design outcomes

Primary

Measure	Time frame
Change from baseline in the mean number of micturitions per 24 hours	12 weeks

Secondary

Measure	Time frame
Change from baseline in the mean number of urgency episodes per 24 hours	12 weeks
Change from baseline in the mean number of incontinence episodes per 24 hours	12 weeks

Countries

Japan

Outcome results

None listed

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