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A Phase II Study of KUC-7483 in Patients With Overactive Bladder

This study has been completed.
Sponsor:
Information provided by:
Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00742833
First received: August 5, 2008
Last updated: September 2, 2009
Last verified: September 2009
History of Changes
  Purpose

To investigate the efficacy and safety of KUC-7483 in overactive bladder patients.


Condition Intervention Phase
Overactive Bladder (OAB)
 Drug: KUC-7483
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo Controlled, Phase II Study of KUC-7483 in Patients With Overactive Bladder

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Change from baseline in mean number of micturitions per 24 hours [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in mean number of urgency episodes per 24 hours [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of incontinence episodes per 24 hours [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Arms Assigned Interventions
Experimental: 3 Drug: KUC-7483
Placebo Comparator: 1 Drug: Placebo

  Eligibility

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

Inclusion Criteria:

  • Patients with a symptom of overactive bladder for more than 6 months.

  • Patients who meet the following condition during the 3-day bladder diary period.

    • the mean number of micturitions per 24 hours is ≥8 times
    • the mean number of urgency episodes per 24 hours is ≥1 time

Exclusion Criteria:

  • Patients who are diagnosed as stress urinary incontinence are predominant.
  • Patients with urinary calculus, interstitial cystitis, or clinically significant urinary tract infection.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00742833

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

No publications provided

ClinicalTrials.gov Identifier: NCT00742833     History of Changes
Other Study ID Numbers: KUC1203
Study First Received: August 5, 2008
Last Updated: September 2, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kissei Pharmaceutical Co., Ltd.:
Overactive bladder
Frequency
Micturition
 Urgency
Urge urinary incontinence
β3-agonist

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

ClinicalTrials.gov processed this record on May 23, 2013