Multiple SclerosisPhase 4SONICNCT00629642
Clinical Study of Solifenacin Succinate in Patients With Bladder Symptoms Due to Spinal Cord Injury or Multiple Sclerosis
A Phase 4 study testing Solifenacin Succinate and Oxybutynin Hydrochloride in people with Multiple Sclerosis and Neurogenic Bladder, run by Astellas Pharma Inc at 39 sites in 11 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Neurogenic Bladder, Spinal Cord Diseases
- What is being tested?
- Solifenacin Succinate and Oxybutynin Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 249 participants
- Where
- 39 sitesin 11 countries
- Study dates
- 14 Mar 2008to 28 Jan 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
39 sites in 11 countries.
39 sites in 11 countries
Belgium6 sites
Study site
Antwerp
Study site
Esneux
Study site
Fraiture-en-Condroz
Study site
Ghent
Study site
Leuven
Study site
Melsbroek
Australia4 sites
Study site
Brisbane
Study site
Melbourne
Study site
Perth
Study site
Randwick
France4 sites
Study site
Caen
Study site
Garches
Study site
Paris
Study site
Ploemeur
Germany4 sites
Study site
Berlin
Study site
Hagenow
Study site
Heidelberg
Study site
Kiel
Italy4 sites
Study site
Florence
Study site
Milan
Study site
Rome
Study site
Torino
Spain4 sites
Study site
A Coruña
Study site
Badalona, Barcelona
Study site
Getafe, Madrid
Study site
Sant Joan d'Alacant, Alicante
Netherlands3 sites
Study site
Apeldoorn
Study site
Eindhoven
Study site
Nijmegen
Russia2 sites
Study site
Saint Petersburg, 190089
Study site
Saint Petersburg, 196084
About this study
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
A clinical study to evaluate the efficacy and safety of solifenacin in patients with bladder symptoms due to spinal cord injury or multiple sclerosis
Read the 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.
- Conditions
- Multiple Sclerosis, Neurogenic Bladder, Spinal Cord Diseases
- Being tested
- Solifenacin Succinate, Oxybutynin Hydrochloride, Placebo
- Keywords
- Neurogenic bladder, Vesicare
- Medical subject headings
- Multiple Sclerosis, Urinary Bladder, Neurogenic, Spinal Cord Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solifenacin SuccinateDrug
Also called Vesicare, YM905
Oral, 10mg
Solifenacin SuccinateDrug
Also called Vesicare, YM905
Oral, 5mg
Oxybutynin HydrochlorideDrug
Oral, 15mg
PlaceboDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| I.Solifenacin succinate 10mg (2x5mg 1/day) | Experimental | Oral Receives: Drug: Solifenacin Succinate |
| II.Solifenacin succinate 5mg (5mg 1/day) | Experimental | Oral Receives: Drug: Solifenacin Succinate |
| III.Oxybutynin hydrochloride 15mg (5mg 3/day) | Active comparator | Oral Receives: Drug: Oxybutynin Hydrochloride |
| IV. Placebo | Placebo comparator | Oral Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in maximum cystometric capacity
Measured: 4 Weeks
Secondary outcomes (7)
Change from baseline in bladder volume at first involuntary contraction
Measured: 4 Weeks
Change from baseline in pressure at first leak
Measured: 4 Weeks
Change from baseline in volume at first leak
Measured: 4 Weeks
Change from baseline in maximum detrusor pressure
Measured: 4 Weeks
Change from baseline in micturition or catheterization frequency
Measured: 4 Weeks
Change from baseline in incontinence episodes
Measured: 4 Weeks
Incidence and severity of adverse events
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2008 (estimated)
- Study start14 Mar 2008
- Primary completion28 Jan 2011
- Study completion28 Jan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Department of (Neuro) Urology, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00629642
- Sponsor's protocol ID
- 905-EC-005
- Other IDs
- 2006-005523-42
- Acronym
- SONIC
- Status last verified
- Nov 2024
- First submitted
- 26 Feb 2008
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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/.
Publications
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.
PubMed 37160401
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00629642
- Acronym / sponsor ID
- SONIC / 905-EC-005
- Conditions
- Multiple Sclerosis, Neurogenic Bladder, Spinal Cord Diseases
- Keywords
- Neurogenic bladder, Vesicare
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2008 (actual)
- Primary completion
- 28 Jan 2011 (actual)
- Study completion
- 28 Jan 2011 (actual)
- First posted
- 6 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| I.Solifenacin succinate 10mg (2x5mg 1/day) | Experimental | Drug: Solifenacin SuccinateOral |
| II.Solifenacin succinate 5mg (5mg 1/day) | Experimental | Drug: Solifenacin SuccinateOral |
| III.Oxybutynin hydrochloride 15mg (5mg 3/day) | Active comparator | Drug: Oxybutynin HydrochlorideOral |
| IV. Placebo | Placebo comparator | Drug: PlaceboOral |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent has been obtained
- Subjects with neurogenic detrusor overactivity due to:
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solifenacin SuccinateAlso: Vesicare, YM905Oral, 10mg | Drug | I.Solifenacin succinate 10mg (2x5mg 1/day) |
| Solifenacin SuccinateAlso: Vesicare, YM905Oral, 5mg | Drug | II.Solifenacin succinate 5mg (5mg 1/day) |
| Oxybutynin HydrochlorideOral, 15mg | Drug | III.Oxybutynin hydrochloride 15mg (5mg 3/day) |
| PlaceboOral | Drug | IV. Placebo |
Primary outcome
Change from baseline in maximum cystometric capacity
Time frame: 4 Weeks
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Derived from this study: PubMed 37160401Stoniute 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.
- Individual participant dataSharing planned: Yes. 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/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Department of (Neuro) Urology principal investigator
Universitaire Ziekenhuizen KU Leuven
39 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Solifenacin Succinate and Oxybutynin Hydrochloride in people with Multiple Sclerosis and Neurogenic Bladder, run by Astellas Pharma Inc at 39 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Belgium, Australia, France, Germany, Italy and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in maximum cystometric capacity (time frame: 4 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00629642, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.