Safety and Efficacy of SAF312 in Patients With Neurogenic Detrusor Overactivity Due to Spinal Cord Lesions
NCT ID: NCT01598103
Last Updated: 2020-12-19
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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TERMINATED
PHASE2
9 participants
INTERVENTIONAL
2012-01-31
2012-09-30
Brief Summary
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Detailed Description
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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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Placebo to SAF312
Placebo to SAF312
One week of treatment in a BID (two times a day) regimen (hard gelatin capsules for oral use)
SAF312
SAF312
One week of treatment in a BID (two times a day) regimen (hard gelatin capsules for oral use)
Interventions
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SAF312
One week of treatment in a BID (two times a day) regimen (hard gelatin capsules for oral use)
Placebo to SAF312
One week of treatment in a BID (two times a day) regimen (hard gelatin capsules for oral use)
Eligibility Criteria
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Inclusion Criteria
* Patients are inadequately managed by antimuscarinic medication and present with a cystometric bladder capacity of max. 400 mL
Exclusion Criteria
* Pelvic or genitourinary tract anomalies including surgery or bladder disease other than detrusor overactivity impacting on bladder function
18 Years
65 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Murnau am Staffelsee, , Germany
Novartis Investigative Site
Nijmegen, , Netherlands
Novartis Investigative Site
Zurich, , Switzerland
Countries
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References
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Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.
Schafer W, Abrams P, Liao L, Mattiasson A, Pesce F, Spangberg A, Sterling AM, Zinner NR, van Kerrebroeck P; International Continence Society. Good urodynamic practices: uroflowmetry, filling cystometry, and pressure-flow studies. Neurourol Urodyn. 2002;21(3):261-74. doi: 10.1002/nau.10066.
Stohrer M, Blok B, Castro-Diaz D, Chartier-Kastler E, Del Popolo G, Kramer G, Pannek J, Radziszewski P, Wyndaele JJ. EAU guidelines on neurogenic lower urinary tract dysfunction. Eur Urol. 2009 Jul;56(1):81-8. doi: 10.1016/j.eururo.2009.04.028. Epub 2009 Apr 21.
Related Links
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Results for CSAF312A2202 on the Novartis clinical trials website
Other Identifiers
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2010-021137-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CSAF312A2202
Identifier Type: -
Identifier Source: org_study_id