A Phase II Study of KUC-7483 in Patients With Overactive Bladder

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00742833

Enrollment

400

Registered

2008-08-28

Start date

Unknown

Completion date

Unknown

Last updated

2009-09-04

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

Conditions

Overactive Bladder (OAB)

Keywords

Overactive bladder, Frequency, Micturition, Urgency, Urge urinary incontinence, β3-agonist

Brief summary

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

Interventions

DRUGKUC-7483

DRUGPlacebo

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 mean number of micturitions per 24 hours	12 weeks

Secondary

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

Countries

Japan

Outcome results

None listed

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