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A Confirmatory 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:
NCT01004315
First received: October 27, 2009
Last updated: July 25, 2010
Last verified: July 2010
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  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: NCT01004315

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: 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
Frequency
Micturition
 Urgency
Urge urinary incontinence
OAB

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Tolterodine
Muscarinic Antagonists
 Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013