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This study has been withdrawn prior to enrollment.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Lower Urinary Tract Symptoms
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on October 21, 2014