Long-term Safety and Efficacy of KUC-7483 in Patients With Overactive Bladder

Phase 3

Withdrawn

• Conditions: Overactive Bladder
• Interventions: Drug: KUC-7483

• Registration Number: NCT01003405
• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Brief Summary

To investigate the long-term safety, efficacy and pharmacokinetics of KUC-7483 in patients with overactive bladder.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-27
• Study First Submitted QC: 2009-10-27
• Study First Posted: 2009-10-28
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-25
• Last Update Posted: 2010-07-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients who have successfully completed the Phase III double-blind study.

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Exclusion Criteria

• Patients with serious adverse events or clinically significant adverse events in the Phase III double-blind study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KUC-7483	KUC-7483	-

Primary Outcome Measures

Name	Time	Method
The long-term safety of KUC-7483 for the treatment of overactive bladder.	52 weeks

Secondary Outcome Measures

Name	Time	Method
The long-term efficacy of KUC-7483 for the treatment of overactive bladder.	52 weeks

Trial Locations

Locations (1)

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