Open-label Long-term Extension Study of Fesoterodine in Japanese Subjects With Neurogenic Detrusor Overactivity.
NCT ID: NCT02501928
Last Updated: 2020-11-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
12 participants
INTERVENTIONAL
2015-06-05
2020-04-01
Brief Summary
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Detailed Description
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This study consists of a 28-week open-label treatment period followed by a 4-week follow-up. In addition, subjects in the oxybutynin arm of the precedent Study A0221047 will continue the fesoterodine treatment until Week 40 visit in this study, in order to obtain fesoterodine 1 year treatment data.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
TREATMENT
NONE
Study Groups
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Fesoterodine PR 4 mg
Fesoterodine PR 4 mg for 28 or 40 weeks in open-label treatment period
Fesoterodine PR 4 mg
Fesoterodine 4 mg tablet once daily for 28 or 40 weeks
Fesoterodine PR 8 mg
Fesoterodine PR 8 mg for 28 or 40 weeks in open-label treatment period
Fesoterodine PR 8 mg
Fesoterodine PR 8 mg tablet once daily for 28 or 40 weeks
Fesoterodine BIC 2 mg
Fesoterodine BIC 2 mg for 28 weeks in open-label treatment period
Fesoterodine BIC 2 mg
Fesoterodine BIC 2 mg tablet once daily for 28 weeks
Fesoterodine BIC 4 mg
Fesoterodine BIC 4 mg for 28 weeks in open-label treatment period
Fesoterodine BIC 4 mg
Fesoterodine BIC 4 mg tablet once daily for 28 weeks
Interventions
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Fesoterodine PR 4 mg
Fesoterodine 4 mg tablet once daily for 28 or 40 weeks
Fesoterodine PR 8 mg
Fesoterodine PR 8 mg tablet once daily for 28 or 40 weeks
Fesoterodine BIC 2 mg
Fesoterodine BIC 2 mg tablet once daily for 28 weeks
Fesoterodine BIC 4 mg
Fesoterodine BIC 4 mg tablet once daily for 28 weeks
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Concomitant medications which may increase the risk to subjects or confound study results
* Other medical conditions which may increase the risk to subjects or confound study results
6 Years
17 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Aichi Children's Health and Medical Center
Ōbu, Aichi-ken, Japan
Chiba Children's Hospital
Midori-ku Chiba-shi, Chiba, Japan
Fukuoka Children's Hospital
Fukuoka, Fukuoka, Japan
Kanagawa Children's Medical Center
Yokohama, Kanagawa, Japan
Osaka Women's and Children's Hospital
Izumi-shi, Osaka, Japan
Shizuoka Children's Hospital
Aoi-ku Shizuoka-shi, Shizuoka, Japan
Dokkyo Medical University Hospital
Shimotsuga-gun, Tochigi, Japan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A0221109
Identifier Type: -
Identifier Source: org_study_id