Clinical Study of Solifenacin Succinate in Patients With Bladder Symptoms Due to Spinal Cord Injury or Multiple Sclerosis (SONIC)
Primary Purpose
Multiple Sclerosis, Neurogenic Bladder, Spinal Cord Diseases
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Solifenacin Succinate
Solifenacin Succinate
Oxybutynin Hydrochloride
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Neurogenic bladder, Vesicare
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
I.Solifenacin succinate 10mg (2x5mg 1/day)
II.Solifenacin succinate 5mg (5mg 1/day)
III.Oxybutynin hydrochloride 15mg (5mg 3/day)
IV. Placebo
Arm Description
Oral
Oral
Oral
Oral
Outcomes
Primary Outcome Measures
Change from baseline in maximum cystometric capacity
Secondary Outcome Measures
Change from baseline in bladder volume at first involuntary contraction
Change from baseline in pressure at first leak
Change from baseline in volume at first leak
Change from baseline in maximum detrusor pressure
Change from baseline in micturition or catheterization frequency
Change from baseline in incontinence episodes
Incidence and severity of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00629642
Brief Title
Clinical Study of Solifenacin Succinate in Patients With Bladder Symptoms Due to Spinal Cord Injury or Multiple Sclerosis
Acronym
SONIC
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
March 14, 2008 (Actual)
Primary Completion Date
January 28, 2011 (Actual)
Study Completion Date
January 28, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Neurogenic Bladder, Spinal Cord Diseases
Keywords
Neurogenic bladder, Vesicare
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
249 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I.Solifenacin succinate 10mg (2x5mg 1/day)
Arm Type
Experimental
Arm Description
Oral
Arm Title
II.Solifenacin succinate 5mg (5mg 1/day)
Arm Type
Experimental
Arm Description
Oral
Arm Title
III.Oxybutynin hydrochloride 15mg (5mg 3/day)
Arm Type
Active Comparator
Arm Description
Oral
Arm Title
IV. Placebo
Arm Type
Placebo Comparator
Arm Description
Oral
Intervention Type
Drug
Intervention Name(s)
Solifenacin Succinate
Other Intervention Name(s)
Vesicare, YM905
Intervention Description
Oral, 10mg
Intervention Type
Drug
Intervention Name(s)
Solifenacin Succinate
Other Intervention Name(s)
Vesicare, YM905
Intervention Description
Oral, 5mg
Intervention Type
Drug
Intervention Name(s)
Oxybutynin Hydrochloride
Intervention Description
Oral, 15mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral
Primary Outcome Measure Information:
Title
Change from baseline in maximum cystometric capacity
Time Frame
4 Weeks
Secondary Outcome Measure Information:
Title
Change from baseline in bladder volume at first involuntary contraction
Time Frame
4 Weeks
Title
Change from baseline in pressure at first leak
Time Frame
4 Weeks
Title
Change from baseline in volume at first leak
Time Frame
4 Weeks
Title
Change from baseline in maximum detrusor pressure
Time Frame
4 Weeks
Title
Change from baseline in micturition or catheterization frequency
Time Frame
4 Weeks
Title
Change from baseline in incontinence episodes
Time Frame
4 Weeks
Title
Incidence and severity of adverse events
Time Frame
4 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Department of (Neuro) Urology
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
City
Brisbane
Country
Australia
City
Melbourne
Country
Australia
City
Perth
Country
Australia
City
Randwick
Country
Australia
City
Antwerpen
Country
Belgium
City
Esneux
Country
Belgium
City
Fraiture-en-Condroz
Country
Belgium
City
Gent
Country
Belgium
City
Leuven
Country
Belgium
City
Melsbroek
Country
Belgium
City
Brno
Country
Czechia
City
Ceske Budejovice
Country
Czechia
City
Prague
Country
Czechia
City
Caen
Country
France
City
Garches
Country
France
City
Paris
Country
France
City
Ploemeur
Country
France
City
Berlin
Country
Germany
City
Hagenow
Country
Germany
City
Heidelberg
Country
Germany
City
Kiel
Country
Germany
City
Nyiregyhaza
Country
Hungary
City
Sopron
Country
Hungary
City
Szeged
Country
Hungary
City
Firenze
Country
Italy
City
Milan
Country
Italy
City
Rome
Country
Italy
City
Torino
Country
Italy
City
Apeldoorn
Country
Netherlands
City
Eindhoven
Country
Netherlands
City
Nijmegen
Country
Netherlands
City
St. Petersburg
ZIP/Postal Code
190089
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
196084
Country
Russian Federation
City
San Juan de Alicante
State/Province
Alicante
Country
Spain
City
Badalona
State/Province
Barcelona
Country
Spain
City
Getafe
State/Province
Madrid
Country
Spain
City
La Coruna
Country
Spain
City
Cardiff
Country
United Kingdom
City
Newcastle Upon Tyne
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.
Links:
URL
https://www.astellasclinicalstudyresults.com/study.aspx?ID=213
Description
Link to results on the Astellas Clinical Study Results website.
Learn more about this trial
Clinical Study of Solifenacin Succinate in Patients With Bladder Symptoms Due to Spinal Cord Injury or Multiple Sclerosis
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