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

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ClinicalTrials.gov Identifier: NCT00629642
Recruitment Status : Completed
First Posted : March 6, 2008
Last Update Posted : September 1, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Multiple Sclerosis Neurogenic Bladder Spinal Cord Diseases Drug: Solifenacin Succinate Drug: Oxybutynin Hydrochloride Drug: Placebo Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 249 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Actual Study Start Date : March 14, 2008
Primary Completion Date : January 28, 2011
Study Completion Date : January 28, 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline in maximum cystometric capacity [ Time Frame: 4 Weeks ]

Secondary Outcome Measures :
  1. Change from baseline in bladder volume at first involuntary contraction [ Time Frame: 4 Weeks ]
  2. Change from baseline in pressure at first leak [ Time Frame: 4 Weeks ]
  3. Change from baseline in volume at first leak [ Time Frame: 4 Weeks ]
  4. Change from baseline in maximum detrusor pressure [ Time Frame: 4 Weeks ]
  5. Change from baseline in micturition or catheterization frequency [ Time Frame: 4 Weeks ]
  6. Change from baseline in incontinence episodes [ Time Frame: 4 Weeks ]
  7. Incidence and severity of adverse events [ Time Frame: 4 Weeks ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00629642     History of Changes
Other Study ID Numbers: 905-EC-005
2006-005523-42 ( Other Identifier: EudraCT )
First Posted: March 6, 2008    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.
URL: http://

Keywords provided by Astellas Pharma Inc:
Neurogenic bladder
Vesicare

Additional relevant MeSH terms:
Spinal Cord Diseases
Sclerosis
Multiple Sclerosis
Urinary Bladder, Neurogenic
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neurologic Manifestations
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms
Central Nervous System Diseases
Solifenacin Succinate
Oxybutynin
Mandelic Acids
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Anti-Infective Agents, Urinary