Mirabegron and Oxybutynin Safety and Efficacy Trial in Spinal Cord Injury
NCT ID: NCT03187795
Last Updated: 2019-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
62 participants
INTERVENTIONAL
2019-04-03
2022-03-30
Brief Summary
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Detailed Description
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Neurogenic detrusor overactivity is most commonly treated with a medication called oxybutynin (Ditropan); however, this medication is associated with side effects such as dry mouth and constipation. Mirabegron (Myrbetriq) is a newer medication approved by the Food and Drug Administration for the treatment of overactive bladder that does not cause dry mouth or constipation; however, its use in persons with SCI is investigational.
The purpose of this research study is to determine the effectiveness and safety of mirabegron compared to oxybutynin chloride immediate release (oxybutynin IR) for neurogenic detrusor overactivity in individuals with SCI.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Oxybutynin chloride IR then Mirabegron
Subjects randomized to this group will receive oxybutynin IR (5 mg three times daily) for 6 weeks. After the initial 6 weeks, subjects in this group will then be switched to an escalating dose of mirabegron for 6 weeks (25 mg once daily for 2 weeks, followed by 50 mg once daily for 4 weeks; Note: two placebo daily will be included with mirabegron once daily to match the frequency of dosing to oxybutynin IR three times daily).
Oxybutynin Chloride IR
Oxybutynin chloride immediate release (IR) 5 mg three times daily for 6 weeks
Mirabegron
Mirabegron 25 mg tablet once daily for 2 weeks, followed by mirabegron 50 mg once daily for 4 weeks (Note: Placebo twice daily will be included with mirabegron once daily to match the three-time daily dosing of oxybutynin IR in the other intervention).
Mirabegron then Oxybutynin chloride IR
Subjects randomized to this group will receive an escalating dose of mirabegron for 6 weeks (25 mg once daily for 2 weeks, followed by 50 mg once daily for 4 weeks; Note: two placebo daily will be included with mirabegron once daily to match the frequency of dosing to oxybutynin IR three times daily). After the initial 6 weeks, subjects in this group will then be switched to receive oxybutynin IR (5 mg three times daily) for 6 weeks
Oxybutynin Chloride IR
Oxybutynin chloride immediate release (IR) 5 mg three times daily for 6 weeks
Mirabegron
Mirabegron 25 mg tablet once daily for 2 weeks, followed by mirabegron 50 mg once daily for 4 weeks (Note: Placebo twice daily will be included with mirabegron once daily to match the three-time daily dosing of oxybutynin IR in the other intervention).
Interventions
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Oxybutynin Chloride IR
Oxybutynin chloride immediate release (IR) 5 mg three times daily for 6 weeks
Mirabegron
Mirabegron 25 mg tablet once daily for 2 weeks, followed by mirabegron 50 mg once daily for 4 weeks (Note: Placebo twice daily will be included with mirabegron once daily to match the three-time daily dosing of oxybutynin IR in the other intervention).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The injury is classified as complete or incomplete (AIS grade A-D) and the neurological level of the injury is above T12.
* The subject's method of bladder management is intermittent catheterization (IC) or indwelling catheter (transurethral or suprapubic).
* There is urodynamic documentation of neurogenic detrusor overactivity (NDO).
* The subject is on a stable dose of oxybutynin IR three times daily.
* The subject is able and willing to comply with the study protocol, including availability for all scheduled clinic visits and locomotor training sessions.
* The subject is able to and has voluntarily given informed consent prior to the performance of any study-specific procedures.
Exclusion Criteria
* The subject has received a botulinum toxin injection to the bladder within one year of the Screening Visit.
* The subject is allergic to mirabegron.
* The subject has a history of uncontrolled autonomic dysreflexia or significant autonomic dysreflexia on urodynamics (systolic BP≥150 mm/Hg).
* The subject has a known history of significant anatomical problems of the upper tracts, including hydronephrosis, kidney stones, or ureteropelvic junction obstruction.
* The subject has a known history or treatment for a non-neurogenic bladder or prostate problem (prostate cancer, bladder cancer).
* The subject has recurrent UTIs, defined as a UTI more than every three months.
* The subject has untreated Grade 3 or above vesicoureteral reflux.
* If female, the subject is pregnant (documented by a urine pregnancy test) or breastfeeding.
* The subject has taken another investigational drug within 30 days before screening.
* The subject has a medical condition that might pose a safety issue or would interfere with interpretation of study results or study conduct.
18 Years
70 Years
ALL
No
Sponsors
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National Institute on Disability, Independent Living, and Rehabilitation Research
FED
Kessler Foundation
OTHER
Responsible Party
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Trevor Dyson-Hudson, M.D.
Director, Spinal Cord Injury Research
Principal Investigators
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Todd A. Linsenmeyer, M.D.
Role: PRINCIPAL_INVESTIGATOR
Kessler Institute for Rehabilitation
Steven C. Kirshblum, M.D.
Role: PRINCIPAL_INVESTIGATOR
Kessler Institute for Rehabilitation
Trevor A. Dyson-Hudson, M.D.
Role: PRINCIPAL_INVESTIGATOR
Kessler Foundation
Locations
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Kessler Institute for Rehabilitation
West Orange, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Todd A. Linsenmeyer, M.D.
Role: primary
Trevor A. Dyson-Hudson, M.D.
Role: backup
Other Identifiers
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D-961-17
Identifier Type: -
Identifier Source: org_study_id