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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00742833 |
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Date of registration:
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05/08/2008 |
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Primary sponsor: |
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Public title:
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A Phase II Study of KUC-7483 in Patients With Overactive Bladder
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Scientific title:
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A Randomized, Double Blind, Placebo Controlled, Phase II Study of KUC-7483 in Patients With Overactive Bladder |
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Date of first enrolment:
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August 2008 |
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Target sample size:
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400 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00742833 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Japan
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Contacts
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Name:
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Yasuhiro Omori |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kissei Pharmaceutical Co., Ltd. |
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Key inclusion & exclusion criteria
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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.
Age minimum:
20 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Overactive Bladder (OAB)
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Intervention(s)
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Drug: KUC-7483
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Drug: Placebo
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Primary Outcome(s)
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Change from baseline in mean number of micturitions per 24 hours
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Change from baseline in mean number of incontinence episodes per 24 hours
[Time Frame: 12 weeks]
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Change from baseline in mean number of urgency episodes per 24 hours
[Time Frame: 12 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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