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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

750 participants

Study Classification

INTERVENTIONAL

Brief Summary

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

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Detailed Description

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Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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KUC-7483

Group Type EXPERIMENTAL

KUC-7483

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tolterodine

Group Type ACTIVE_COMPARATOR

Tolterodine

Intervention Type DRUG

Interventions

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KUC-7483

Intervention Type DRUG

Placebo

Intervention Type DRUG

Tolterodine

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No