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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: |
NCT00224146 |
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Date of registration:
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14/09/2005 |
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Primary sponsor: |
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Public title:
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Transdermal (TDS) Oxybutynin (Oxytrol(r)) in Overactive Bladder
MATRIX |
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Scientific title:
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Multicenter Assessment of Transdermal Therapy in Overactive Bladder With Oxybutynin TDS (MATRIX) |
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Date of first enrolment:
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May 2004 |
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Target sample size:
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2878 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00224146 |
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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: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Naomi V. Dahl, PharmD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Watson Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult patients with one or more symptom of overactive bladder, including urge urinary
incontinence, urgency and/or frequency
Exclusion Criteria:
- Patients for whom Oxytrol(r) is contraindicated.
- Patients treated with Oxytrol(r) prior to participation in this study.
- Patients residing in long-term care facilities or nursing homes.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Overactive Bladder
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Quality of Life
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Urinary Incontinence
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Intervention(s)
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Drug: oxybutynin transdermal delivery system (Oxytrol(r))
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Primary Outcome(s)
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Change in health-related quality of life
[Time Frame: No]
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Secondary Outcome(s)
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Change in other outcomes such as:
[Time Frame: No]
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depression
[Time Frame: No]
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effect of enhanced patient education on any of the above outcomes
[Time Frame: No]
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participant satisfaction
[Time Frame: No]
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work productivity
[Time Frame: No]
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Secondary ID(s)
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MATRIX
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OXY0402
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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