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A Confirmatory Study of KUC-7483 in Patients With Overactive Bladder

This study has been completed.
Information provided by:
Kissei Pharmaceutical Co., Ltd. Identifier:
First received: October 27, 2009
Last updated: July 25, 2010
Last verified: July 2010

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

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

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

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

Estimated Enrollment: 750
Arms Assigned Interventions
Experimental: KUC-7483 Drug: KUC-7483
Placebo Comparator: Placebo Drug: Placebo
Active Comparator: Tolterodine Drug: Tolterodine


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

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
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Please refer to this study by its identifier: NCT01004315

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

No publications provided Identifier: NCT01004315     History of Changes
Other Study ID Numbers: KUC1301
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
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents processed this record on November 25, 2014