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Main
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Note: This record shows only 22 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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19 February 2015 |
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Main ID: |
NCT00368706 |
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Date of registration:
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24/08/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Double-Blind, Paralleled Study Comparing Efficacy/Safety of Solifenacin to Tolterodine in Overactive Bladder Patients
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Scientific title:
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A Randomized, Double-Blind, Paralleled, Active Controlled, Multi-Center Study of the Efficacy and Safety of 5mg Solifenacin Succinate Compared to Tolterodine in Patients With Overactive Bladder |
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Date of first enrolment:
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September 2006 |
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Target sample size:
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246 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00368706 |
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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, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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China
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Contacts
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Name:
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Use Central Contact |
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Address:
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Telephone:
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Email:
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Affiliation:
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Peking University First Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients willing and able to complete the micturition diary correctly
- Patients experiencing frequency of micturition as verified in the diary
- Patients experiencing significant post void residual volume
- OAB symptoms including urinary frequency, urgency or urge incontinence for 3 months
or more.
Exclusion Criteria:
- Significant post void residual volume
- Patients with indwelling catheters or practicing intermittent self- catheterization
- Known or suspected hypersensitivity to solifenacin succinate or other
anticholinergics or lactose
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Urinary Bladder, Overactive
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Intervention(s)
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Drug: tolterodine
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Drug: solifenacin succinate
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Primary Outcome(s)
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Change from baseline in mean number of micturitions per 24 hours
[Time Frame: 8 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: 8 Weeks]
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Change from baseline in mean volume voided per micturition
[Time Frame: 8 Weeks]
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Change from baseline in mean nocturia episodes per 24 hours
[Time Frame: 8 Weeks]
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Change from baseline in mean urgency frequency per 24 hours
[Time Frame: 8 Weeks]
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Secondary ID(s)
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90506/CHoTD01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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