Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
To evaluate the efficacy and the safety of KUC-7483 in overactive bladder patients.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kissei Pharmaceutical Co., Ltd.
Treatments:
p-Hydroxyamphetamine
Tolterodine Tartrate
Criteria
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.