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

Phase 3

Completed

• Conditions: Overactive Bladder
• Interventions: Drug: KUC-7483; Drug: Placebo; Drug: Tolterodine

• Registration Number: NCT01004315
• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-27
• Study First Submitted QC: 2009-10-27
• Study First Posted: 2009-10-29
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-25
• Last Update Posted: 2010-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 750

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KUC-7483	KUC-7483	-
Placebo	Placebo	-
Tolterodine	Tolterodine	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in the mean number of micturitions per 24 hours	12 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Japan; 🇯🇵 Hokkaido,Tohoku,Kanto,Chubu,Kansai,Shikoku,Kyushu, Japan