Fesoterodine for Amelioration of Autonomic Dysreflexia (AD) Following Spinal Cord Injury (SCI)
NCT02676154
Last updated date
ABOUT THIS STUDY
This study will be investigating the effects of fesoterodine on autonomic dysreflexia (AD) in
patients with spinal cord injuries (SCI). The goal of the study is to examine the effect of
increasing daily use of fesoterodine on episodes of high blood pressure triggered by urinary
bladder contractions.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Autonomic Dysreflexia
Sex
Females and Males
Age
18-60 years
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Autonomic DysreflexiaFesoterodine for Amelioration of Autonomic Dysreflexia (AD) Following Spinal Cord Injury (SCI)
NCT02676154
- Vancouver, British Columbia
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information | |||||
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Brief Title ICMJE | Fesoterodine for Amelioration of Autonomic Dysreflexia (AD) Following Spinal Cord Injury (SCI) | ||||
Official Title ICMJE | A Phase II, Open-Label Exploratory Study Investigating the Efficacy of Toviaz for Treatment of Adult Patients With Spinal Cord Injury With Neurogenic Detrusor Overactivity for Amelioration of Autonomic Dysreflexia(PIIR-AK-TOVIAZ-AD) | ||||
Brief Summary | This study will be investigating the effects of fesoterodine on autonomic dysreflexia (AD) in patients with spinal cord injuries (SCI). The goal of the study is to examine the effect of increasing daily use of fesoterodine on episodes of high blood pressure triggered by urinary bladder contractions. | ||||
Detailed Description | This is a Phase 2, open-label exploratory study investigating the efficacy of fesoterodine for treatment of adult patients with spinal cord injuries (SCI) with autonomic dysreflexia (AD) triggered by neurogenic detrusor overactivity (NDO). | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||
Condition ICMJE | Autonomic Dysreflexia | ||||
Intervention ICMJE | Drug: Fesoterodine
4mg, oral, once daily for 12 weeks; dose adjustments may be permitted. Other Name: Toviaz | ||||
Study Arms ICMJE | Fesoterodine
Open-Label Intervention: Drug: Fesoterodine | ||||
Publications * | Walter M, Ramirez AL, Lee AH, Rapoport D, Kavanagh A, Krassioukov AV. Protocol for a phase II, open-label exploratory study investigating the efficacy of fesoterodine for treatment of adult patients with spinal cord injury suffering from neurogenic detrusor overactivity for amelioration of autonomic dysreflexia. BMJ Open. 2018 Nov 21;8(11):e024084. doi: 10.1136/bmjopen-2018-024084. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE | 15 | ||||
Original Estimated Enrollment ICMJE | 20 | ||||
Actual Study Completion Date ICMJE | January 31, 2019 | ||||
Actual Primary Completion Date | January 31, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | The inclusion criteria include, but are not limited to, the following:
The exclusion criteria include, but are not limited to, the following:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 60 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Canada | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02676154 | ||||
Other Study ID Numbers ICMJE | H15-02364 WI207218 ( Other Grant/Funding Number: Pfizer Canada Inc ) | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
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Responsible Party | Andrei Krassioukov, University of British Columbia | ||||
Study Sponsor ICMJE | University of British Columbia | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of British Columbia | ||||
Verification Date | September 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |