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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00629642




Registration number
NCT00629642
Ethics application status
Date submitted
26/02/2008
Date registered
6/03/2008

Titles & IDs
Public title
Clinical Study of Solifenacin Succinate in Patients With Bladder Symptoms Due to Spinal Cord Injury or Multiple Sclerosis
Scientific 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
Secondary ID [1] 0 0
2006-005523-42
Secondary ID [2] 0 0
905-EC-005
Universal Trial Number (UTN)
Trial acronym
SONIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 0 0
Neurogenic Bladder 0 0
Spinal Cord Diseases 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Solifenacin Succinate
Treatment: Drugs - Solifenacin Succinate
Treatment: Drugs - Oxybutynin Hydrochloride
Treatment: Drugs - Placebo

Experimental: I.Solifenacin succinate 10mg (2x5mg 1/day) - Oral

Experimental: II.Solifenacin succinate 5mg (5mg 1/day) - Oral

Active comparator: III.Oxybutynin hydrochloride 15mg (5mg 3/day) - Oral

Placebo comparator: IV. Placebo - Oral


Treatment: Drugs: Solifenacin Succinate
Oral, 10mg

Treatment: Drugs: Solifenacin Succinate
Oral, 5mg

Treatment: Drugs: Oxybutynin Hydrochloride
Oral, 15mg

Treatment: Drugs: Placebo
Oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in maximum cystometric capacity
Timepoint [1] 0 0
4 Weeks
Secondary outcome [1] 0 0
Change from baseline in bladder volume at first involuntary contraction
Timepoint [1] 0 0
4 Weeks
Secondary outcome [2] 0 0
Change from baseline in pressure at first leak
Timepoint [2] 0 0
4 Weeks
Secondary outcome [3] 0 0
Change from baseline in volume at first leak
Timepoint [3] 0 0
4 Weeks
Secondary outcome [4] 0 0
Change from baseline in maximum detrusor pressure
Timepoint [4] 0 0
4 Weeks
Secondary outcome [5] 0 0
Change from baseline in micturition or catheterization frequency
Timepoint [5] 0 0
4 Weeks
Secondary outcome [6] 0 0
Change from baseline in incontinence episodes
Timepoint [6] 0 0
4 Weeks
Secondary outcome [7] 0 0
Incidence and severity of adverse events
Timepoint [7] 0 0
4 Weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/03/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/01/2011
Sample size
Target
Accrual to date
Final
249
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Brisbane
Recruitment hospital [2] 0 0
- Melbourne
Recruitment hospital [3] 0 0
- Perth
Recruitment hospital [4] 0 0
- Randwick
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- Perth
Recruitment postcode(s) [4] 0 0
- Randwick
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerpen
Country [2] 0 0
Belgium
State/province [2] 0 0
Esneux
Country [3] 0 0
Belgium
State/province [3] 0 0
Fraiture-en-Condroz
Country [4] 0 0
Belgium
State/province [4] 0 0
Gent
Country [5] 0 0
Belgium
State/province [5] 0 0
Leuven
Country [6] 0 0
Belgium
State/province [6] 0 0
Melsbroek
Country [7] 0 0
Czechia
State/province [7] 0 0
Brno
Country [8] 0 0
Czechia
State/province [8] 0 0
Ceske Budejovice
Country [9] 0 0
Czechia
State/province [9] 0 0
Prague
Country [10] 0 0
France
State/province [10] 0 0
Caen
Country [11] 0 0
France
State/province [11] 0 0
Garches
Country [12] 0 0
France
State/province [12] 0 0
Paris
Country [13] 0 0
France
State/province [13] 0 0
Ploemeur
Country [14] 0 0
Germany
State/province [14] 0 0
Berlin
Country [15] 0 0
Germany
State/province [15] 0 0
Hagenow
Country [16] 0 0
Germany
State/province [16] 0 0
Heidelberg
Country [17] 0 0
Germany
State/province [17] 0 0
Kiel
Country [18] 0 0
Hungary
State/province [18] 0 0
Nyiregyhaza
Country [19] 0 0
Hungary
State/province [19] 0 0
Sopron
Country [20] 0 0
Hungary
State/province [20] 0 0
Szeged
Country [21] 0 0
Italy
State/province [21] 0 0
Firenze
Country [22] 0 0
Italy
State/province [22] 0 0
Milan
Country [23] 0 0
Italy
State/province [23] 0 0
Rome
Country [24] 0 0
Italy
State/province [24] 0 0
Torino
Country [25] 0 0
Netherlands
State/province [25] 0 0
Apeldoorn
Country [26] 0 0
Netherlands
State/province [26] 0 0
Eindhoven
Country [27] 0 0
Netherlands
State/province [27] 0 0
Nijmegen
Country [28] 0 0
Russian Federation
State/province [28] 0 0
St. Petersburg
Country [29] 0 0
Spain
State/province [29] 0 0
Alicante
Country [30] 0 0
Spain
State/province [30] 0 0
Barcelona
Country [31] 0 0
Spain
State/province [31] 0 0
Madrid
Country [32] 0 0
Spain
State/province [32] 0 0
La Coruna
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Cardiff
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Newcastle Upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Astellas Pharma Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Department of (Neuro) Urology
Address 0 0
Universitaire Ziekenhuizen KU Leuven
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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/.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.clinicaltrials.astellas.com/transparency/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT00629642