Clinical Study of Solifenacin Succinate in Patients With Bladder Symptoms Due to Spinal Cord Injury or Multiple Sclerosis (SONIC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00629642
First received: February 26, 2008
Last updated: March 4, 2013
Last verified: September 2012
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
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: March 4, 2013
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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
Solifenacin
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 August 20, 2014