Clinical Study of Solifenacin Succinate in Patients With Bladder Symptoms Due to Spinal Cord Injury or Multiple Sclerosis
SONIC
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
2 other identifiers
interventional
249
11 countries
39
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 multiple-sclerosis
Started Mar 2008
Typical duration for phase_4 multiple-sclerosis
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2008
CompletedFirst Posted
Study publicly available on registry
March 6, 2008
CompletedStudy Start
First participant enrolled
March 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 28, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 28, 2011
CompletedNovember 14, 2024
November 1, 2024
2.9 years
February 26, 2008
November 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in maximum cystometric capacity
4 Weeks
Secondary Outcomes (7)
Change from baseline in bladder volume at first involuntary contraction
4 Weeks
Change from baseline in pressure at first leak
4 Weeks
Change from baseline in volume at first leak
4 Weeks
Change from baseline in maximum detrusor pressure
4 Weeks
Change from baseline in micturition or catheterization frequency
4 Weeks
- +2 more secondary outcomes
Study Arms (4)
I.Solifenacin succinate 10mg (2x5mg 1/day)
EXPERIMENTALOral
II.Solifenacin succinate 5mg (5mg 1/day)
EXPERIMENTALOral
III.Oxybutynin hydrochloride 15mg (5mg 3/day)
ACTIVE COMPARATOROral
IV. Placebo
PLACEBO COMPARATOROral
Interventions
Oral, 10mg
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Unknown Facility
Brisbane, Australia
Unknown Facility
Melbourne, Australia
Unknown Facility
Perth, Australia
Unknown Facility
Randwick, Australia
Unknown Facility
Antwerp, Belgium
Unknown Facility
Esneux, Belgium
Unknown Facility
Fraiture-en-Condroz, Belgium
Unknown Facility
Ghent, Belgium
Unknown Facility
Leuven, Belgium
Unknown Facility
Melsbroek, Belgium
Unknown Facility
Brno, Czechia
Unknown Facility
České Budějovice, Czechia
Unknown Facility
Prague, Czechia
Unknown Facility
Caen, France
Unknown Facility
Garches, France
Unknown Facility
Paris, France
Unknown Facility
Ploemeur, France
Unknown Facility
Berlin, Germany
Unknown Facility
Hagenow, Germany
Unknown Facility
Heidelberg, Germany
Unknown Facility
Kiel, Germany
Unknown Facility
Nyíregyháza, Hungary
Unknown Facility
Sopron, Hungary
Unknown Facility
Szeged, Hungary
Unknown Facility
Florence, Italy
Unknown Facility
Milan, Italy
Unknown Facility
Rome, Italy
Unknown Facility
Torino, Italy
Unknown Facility
Apeldoorn, Netherlands
Unknown Facility
Eindhoven, Netherlands
Unknown Facility
Nijmegen, Netherlands
Unknown Facility
Saint Petersburg, 190089, Russia
Unknown Facility
Saint Petersburg, 196084, Russia
Unknown Facility
Sant Joan d'Alacant, Alicante, Spain
Unknown Facility
Badalona, Barcelona, Spain
Unknown Facility
Getafe, Madrid, Spain
Unknown Facility
A Coruña, Spain
Unknown Facility
Cardiff, United Kingdom
Unknown Facility
Newcastle upon Tyne, United Kingdom
Related Publications (1)
Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
PMID: 37160401DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Department of (Neuro) Urology
Universitaire Ziekenhuizen KU Leuven
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2008
First Posted
March 6, 2008
Study Start
March 14, 2008
Primary Completion
January 28, 2011
Study Completion
January 28, 2011
Last Updated
November 14, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.