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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01004315
First Posted: October 29, 2009
Last Update Posted: July 27, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Kissei Pharmaceutical Co., Ltd.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Change from baseline in the mean number of urgency episodes per 24 hours [ Time Frame: 12 weeks ]
  • Change from baseline in the mean number of incontinence episodes per 24 hours [ Time Frame: 12 weeks ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT01004315     History of Changes
Other Study ID Numbers: KUC1301
First Submitted: October 27, 2009
First Posted: October 29, 2009
Last Update Posted: July 27, 2010
Last Verified: July 2010

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
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Tolterodine Tartrate
p-Hydroxyamphetamine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Sympathomimetics