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| Sponsored by: |
Astellas Pharma Inc |
| Information provided by: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00629642 |
Purpose
A clinical study to evaluate the efficacy and safety of solifenacin in patients with bladder symptoms due to spinal cord injury or multiple sclerosis
| Condition | Intervention | Phase |
|
Urinary Bladder, Neurogenic Spinal Cord Diseases Multiple Sclerosis |
Drug: Solifenacin Succinate Drug: Oxybutynin Hydrochloride Drug: Placebo |
Phase IV |
| MedlinePlus related topics: | Multiple Sclerosis Spinal Cord Diseases Spinal Cord Injuries |
| ChemIDplus related topics: | Succinic acid Solifenacin succinate Solifenacin Oxybutynin Oxybutynin chloride |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double Blind, Double Dummy, Placebo Controlled Study to Evaluate the Efficacy and Safety of Solifenacin Succinate (5 and 10mg Once Daily) Against Placebo and Oxybutynin Hydrochloride (5 mg Three Times Daily) in the Treatment of Subjects With Neurogenic Detrusor Overactivity |
| Estimated Enrollment: | 216 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | January 2009 |
| Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
I: Experimental
Solifenacin succinate 10mg (2x5mg 1/day)
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Drug: Solifenacin Succinate
Oral, 10mg
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II: Experimental
Solifenacin succinate 5mg (5mg 1/day)
|
Drug: Solifenacin Succinate
Oral, 5mg
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III: Active Comparator
Oxybutynin hydrochloride 15mg (5mg 3/day)
|
Drug: Oxybutynin Hydrochloride
Oral, 15mg
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IV: Placebo Comparator
Placebo
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Drug: Placebo
Oral
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A clinical study to compare the efficacy and safety of solifenacin succinate in patients with neurogenic detrusor overactivity. In this randomized, double blind, double dummy study solifenacin will be compared to placebo and an active comparator, oxybutynin hydrochloride. Patients will be randomized to one of four treatment arms; solifenacin 10mg, solifenacin 5mg, placebo or oxybutynin 15mg. Patients will be assessed over a four week treatment period.
Eligibility
| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects with neurogenic detrusor overactivity due to:
Exclusion Criteria:
Contacts and Locations| Contact: Astellas Pharma Europe Medical Information | 44-0-1784-419487 | medical@eu.astellas.com |
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Show 40 Study Locations |
| Astellas Pharma Inc |
| Principal Investigator: | Department of (Neuro) Urology | University Hospital Leuven |
More Information
| Responsible Party: | Astellas Pharma Europe BV ( Disclosure Office Europe ) |
| Study ID Numbers: | 905-EC-005, EudraCT #: 2006-005523-42 |
| First Received: | February 26, 2008 |
| Last Updated: | February 27, 2008 |
| ClinicalTrials.gov Identifier: | NCT00629642 |
| Health Authority: | Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; Czech Republic: State Institute for Drug Control; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Italy: Ethics Committee; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Portugal: National Pharmacy and Medicines Institute; Spain: Spanish Agency of Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Australia: Department of Health and Ageing Therapeutic Goods Administration |
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