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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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:

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 ]

Enrollment:	249
Study Start Date:	March 2008
Study Completion Date:	January 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: I.Solifenacin succinate 10mg (2x5mg 1/day)	Drug: Solifenacin Succinate Oral, 10mg Other Names: Vesicare YM905
Experimental: II.Solifenacin succinate 5mg (5mg 1/day)	Drug: Solifenacin Succinate Oral, 5mg Other Names: Vesicare YM905
Active Comparator: III.Oxybutynin hydrochloride 15mg (5mg 3/day)	Drug: Oxybutynin Hydrochloride Oral, 15mg
Placebo Comparator: IV. Placebo	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

Show 39 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Principal Investigator:

Department of (Neuro) Urology

Universitaire Ziekenhuizen Leuven

More Information

No publications provided

Responsible Party:	Disclosure Office Europe, Astellas Pharma Europe BV
ClinicalTrials.gov Identifier:	NCT00629642 History of Changes
Other Study ID Numbers:	905-EC-005, 2006-005523-42
Study First Received:	February 26, 2008
Last Updated:	February 24, 2011
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:

Urinary Bladder, Neurogenic
Multiple Sclerosis
Sclerosis
Spinal Cord Diseases
Spinal Cord Injuries
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

Pathologic Processes
Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Oxybutynin
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Mandelic Acids
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on February 12, 2012