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

This study has been withdrawn prior to enrollment.
Information provided by:
Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
First received: October 27, 2009
Last updated: July 25, 2010
Last verified: July 2010
To investigate the long-term safety, efficacy and pharmacokinetics of KUC-7483 in patients with overactive bladder.

Condition Intervention Phase
Overactive Bladder
Drug: KUC-7483
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Open-label, Long-term Extension Study of KUC-7483 in Patients With Overactive Bladder

Resource links provided by NLM:

Further study details as provided by Kissei Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • The long-term safety of KUC-7483 for the treatment of overactive bladder. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The long-term efficacy of KUC-7483 for the treatment of overactive bladder. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Arms Assigned Interventions
Experimental: KUC-7483 Drug: KUC-7483


Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01003405

Hokkaido,Tohoku,Kanto,Chubu,Kansai,Shikoku,Kyushu, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
Study Director: Yasuhiro Omori Clinical Development Department, Kissei pharmaceutical Co., Ltd.
  More Information

ClinicalTrials.gov Identifier: NCT01003405     History of Changes
Other Study ID Numbers: KUC1302 
Study First Received: October 27, 2009
Last Updated: July 25, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kissei Pharmaceutical Co., Ltd.:
Overactive bladder
Urge urinary incontinence

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Lower Urinary Tract Symptoms
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on May 26, 2016