Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Astellas Pharma Inc |
---|---|
Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00629642 |
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 |
---|---|---|
Neurogenic Bladder Spinal Cord Diseases Multiple Sclerosis |
Drug: Solifenacin Succinate Drug: Oxybutynin Hydrochloride Drug: Placebo |
Phase IV |
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: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
I: Experimental
Solifenacin succinate 10mg (2x5mg 1/day)
|
Drug: Solifenacin Succinate
Oral, 10mg
|
II: Experimental
Solifenacin succinate 5mg (5mg 1/day)
|
Drug: Solifenacin Succinate
Oral, 5mg
|
III: Active Comparator
Oxybutynin hydrochloride 15mg (5mg 3/day)
|
Drug: Oxybutynin Hydrochloride
Oral, 15mg
|
IV: Placebo Comparator
Placebo
|
Drug: Placebo
Oral
|
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.
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:
Contact: Astellas Pharma Europe Medical Information | 44-0-1784-419487 | medical@eu.astellas.com |
Principal Investigator: | Department of (Neuro) Urology | University Hospital Leuven |
Responsible Party: | Astellas Pharma Europe BV ( Disclosure Office Europe ) |
Study ID Numbers: | 905-EC-005, EudraCT #: 2006-005523-42 |
Study First Received: | February 26, 2008 |
Last Updated: | September 24, 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 |
Neurogenic bladder Vesicare |
Spinal Cord Diseases Roussy Levy hereditary areflexic dystasia Demyelinating diseases Signs and Symptoms Spinal Cord Injuries Multiple Sclerosis Urologic Diseases Neuromuscular Diseases Hereditary Motor and Sensory Neuropathies Mandelic Acids Autoimmune Diseases of the Nervous System Oxybutynin Urinary Bladder, Neurogenic Cystocele |
Autoimmune Diseases Demyelinating Diseases Urinary Bladder Diseases Charcot-Marie-Tooth Disease Central Nervous System Diseases Sclerosis Nerve Compression Syndromes Tomaculous neuropathy Peripheral Nervous System Diseases Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate Neurologic Manifestations Demyelinating Autoimmune Diseases, CNS Charcot Marie Tooth disease |
Anti-Infective Agents Parasympatholytics Neurotransmitter Agents Immune System Diseases Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Anti-Infective Agents, Urinary |
Renal Agents Cholinergic Agents Pharmacologic Actions Muscarinic Antagonists Pathologic Processes Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents |