This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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: August 31, 2017
Last verified: August 2017
  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
Multiple Sclerosis Neurogenic Bladder Spinal Cord Diseases Drug: Solifenacin Succinate Drug: Oxybutynin Hydrochloride Drug: Placebo Phase 4

Study Type: Interventional
Study Design: 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

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 ]

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

Enrollment: 249
Actual Study Start Date: March 14, 2008
Study Completion Date: January 28, 2011
Primary Completion Date: January 28, 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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   (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
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

  Hide Study Locations
Locations
Australia
Brisbane, Australia
Melbourne, Australia
Perth, Australia
Randwick, Australia
Belgium
Antwerpen, Belgium
Esneux, Belgium
Fraiture-en-Condroz, Belgium
Gent, Belgium
Leuven, Belgium
Melsbroek, Belgium
Czechia
Brno, Czechia
Ceske Budejovice, Czechia
Prague, Czechia
France
Caen, France
Garches, France
Paris, France
Ploemeur, France
Germany
Berlin, Germany
Hagenow, Germany
Heidelberg, Germany
Kiel, Germany
Hungary
Nyiregyhaza, Hungary
Sopron, Hungary
Szeged, Hungary
Italy
Firenze, Italy
Milan, Italy
Rome, Italy
Torino, Italy
Netherlands
Apeldoorn, Netherlands
Eindhoven, Netherlands
Nijmegen, Netherlands
Russian Federation
St. Petersburg, Russian Federation, 190089
St. Petersburg, Russian Federation, 196084
Spain
San Juan de Alicante, Alicante, Spain
Badalona, Barcelona, Spain
Getafe, Madrid, Spain
La Coruna, Spain
United Kingdom
Cardiff, United Kingdom
Newcastle Upon Tyne, United Kingdom
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 )
Study First Received: February 26, 2008
Last Updated: August 31, 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:
Sclerosis
Multiple Sclerosis
Urinary Bladder, Neurogenic
Spinal Cord Diseases
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

ClinicalTrials.gov processed this record on September 21, 2017