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

Overactive Bladder Clinical Trial

Official title:

A Open-label, Long-term Extension Study of KUC-7483 in Patients With Overactive Bladder

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01003405
• Other study ID #: KUC1302
• Status: Withdrawn
• Phase: Phase 3
• First received: October 27, 2009
• Last updated: July 25, 2010

Study information

• Verified date: July 2010
• Source: Kissei Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 100
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• KUC-7483

Locations

Country	Name	City	State
Japan	Japan	Hokkaido,Tohoku,Kanto,Chubu,Kansai,Shikoku,Kyushu

Sponsors (1)

Lead Sponsor	Collaborator
Kissei Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The long-term safety of KUC-7483 for the treatment of overactive bladder.		52 weeks	Yes
Secondary	The long-term efficacy of KUC-7483 for the treatment of overactive bladder.		52 weeks	No