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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01003405
First received: October 27, 2009
Last updated: July 25, 2010
Last verified: July 2010
  Purpose

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

  Eligibility

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

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

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

No publications provided

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
Frequency
Micturition
Urgency
Urge urinary incontinence
OAB

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

ClinicalTrials.gov processed this record on April 15, 2014