Clinical Study of Solifenacin Succinate in Patients With Bladder Symptoms Due to Spinal Cord Injury or Multiple Sclerosis - Full Text View

Sponsor:	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
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

Resource links provided by NLM:

Genetics Home Reference related topics: Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

MedlinePlus related topics: Multiple Sclerosis Spinal Cord Diseases Spinal Cord Injuries

Drug Information available for: Succinic acid Solifenacin Solifenacin succinate Oxybutynin chloride Oxybutynin

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Change from baseline in maximum cystometric capacity [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in bladder volume at first involuntary contraction [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
Change from baseline in pressure at first leak [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
Change from baseline in volume at first leak [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
Change from baseline in maximum detrusor pressure [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
Change from baseline in micturition or catheterization frequency [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
Change from baseline in incontinence episodes [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
Incidence and severity of adverse events [ Time Frame: 4 Weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	216
Study Start Date:	March 2008
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I.Solifenacin succinate 10mg (2x5mg 1/day): Experimental	Drug: Solifenacin Succinate Oral, 10mg
II.Solifenacin succinate 5mg (5mg 1/day): Experimental	Drug: Solifenacin Succinate Oral, 5mg
III.Oxybutynin hydrochloride 15mg (5mg 3/day): Active Comparator	Drug: Oxybutynin Hydrochloride Oral, 15mg
IV. Placebo: Placebo Comparator	Drug: Placebo Oral

Detailed Description:

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

Criteria

Inclusion Criteria:

Written informed consent has been obtained
Subjects with neurogenic detrusor overactivity due to:
- Multiple sclerosis(MS)(EDSS≤8) or
- Spinal cord injury(SCI)(partial or complete lesions)
MS or SCI symptoms should be stable for >= 6 months
Neurogenic detrusor overactivity symptoms should be stable for >= 6 months
Subject is willing and able to perform clean, intermittent, catheterization, if required
Subject is willing and able to take study medication in compliance with the protocol

Exclusion Criteria:

Subjects with neurogenic detrusor overactivity due to Parkinson's or cerebrovascular disease
Subjects with Sjögren's Syndrome or any similar symptoms
Subjects with evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
Subjects with stress incontinence or mixed incontinence where stress is the predominant factor as determined by the investigator
Subjects with evidence of pressure sores >= grade 2
Subjects with a history of bladder sphincterotomy
Subjects with known history of vesico-ureteral reflux without upper urinary tract infection
Any clinically significant condition, which in the opinion of the investigator makes the subject unsuitable for the study or includes a history of acute urinary retention, severe gastrointestinal obstruction (including paralytic ileus or intestinal atony), severe gastrointestinal conditions (including toxic megacolon or ulcerative colitis), myasthenia gravis, narrow angle glaucoma or shallow anterior chamber
Subjects undergoing hemodialysis
Subjects with severe hepatic impairment
Concurrent use of drugs intended to treat symptoms of overactive bladder
Use of antidepressants or muscle relaxants which have not been administered at a constant dose for >= 3 months
Use of non-drug treatment intended to treat overactive bladder symptoms including electrostimulation therapy, botulinum toxin and vanilloids therapy in the six months prior to the commencement of the study
Use of permanent, indwelling catheters
Known or suspected hypersensitivity to solifenacin succinate, oxybutynin hydrochloride, other anti cholinergics or lactose
Concomitant use of a strong CYP3A4 inhibitor, e.g. ketoconazole
Pregnant women, women who intend to become pregnant during the study, women of childbearing potential who are sexually active and practicing an unreliable method of birth control or women who will be lactating during the study. Reliable contraceptive methods are intra-uterine devices, contraceptive pills of combination type, hormonal implants and injectable contraceptives
Participation in any clinical study within 30 days of randomization, or the limit set by national law, whichever is longer
Employees of the Astellas Group, third parties associated with the study, or the study site
Subjects with maximum bladder capacity >= 400ml at visit 2

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00629642

Contacts

Contact: Astellas Pharma Europe Medical Information

44-0-1784-419487

medical@eu.astellas.com

Show 41 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Principal Investigator:

Department of (Neuro) Urology

University Hospital Leuven

More Information

No publications provided

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:	November 2, 2009
ClinicalTrials.gov Identifier:	NCT00629642 History of Changes
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

Keywords provided by Astellas Pharma Inc:

Neurogenic bladder
Vesicare

Additional relevant MeSH terms:

Anti-Infective Agents
Parasympatholytics
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Spinal Cord Diseases
Physiological Effects of Drugs
Renal Agents
Cholinergic Agents
Signs and Symptoms
Multiple Sclerosis
Pathologic Processes
Neuromuscular Diseases
Urologic Diseases
Therapeutic Uses

Mandelic Acids
Autoimmune Diseases of the Nervous System
Urinary Bladder, Neurogenic
Oxybutynin
Autoimmune Diseases
Demyelinating Diseases
Immune System Diseases
Urinary Bladder Diseases
Nervous System Diseases
Central Nervous System Diseases
Anti-Infective Agents, Urinary
Sclerosis
Pharmacologic Actions
Muscarinic Antagonists
Nerve Compression Syndromes

ClinicalTrials.gov processed this record on November 25, 2009