Clinical Study of Solifenacin Succinate in Patients With Bladder Symptoms Due to Spinal Cord Injury or Multiple Sclerosis
Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neurogenic Bladder; Spinal Cord Diseases; Multiple Sclerosis
Intervention: Solifenacin Succinate (Drug); Solifenacin Succinate (Drug); Oxybutynin Hydrochloride (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s): Department of (Neuro) Urology, Principal Investigator, Affiliation: Universitaire Ziekenhuizen Leuven
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
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change from baseline in maximum cystometric capacity
Secondary outcome: Change from baseline in bladder volume at first involuntary contractionChange 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
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Brisbane, Australia
Melbourne, Australia
Perth, Australia
Randwick, Australia
Antwerpen, Belgium
Esneux, Belgium
Fraiture-en-Condroz, Belgium
Gent, Belgium
Leuven, Belgium
Melsbroek, Belgium
Brno, Czech Republic
Ceske Budejovice, Czech Republic
Prague, Czech Republic
Caen, France
Garches, France
Paris, France
Ploemeur, France
Berlin, Germany
Hagenow, Germany
Heidelberg, Germany
Kiel, Germany
Nyiregyhaza, Hungary
Sopron, Hungary
Szeged, Hungary
Firenze, Italy
Milan, Italy
Rome, Italy
Torino, Italy
Apeldoorn, Netherlands
Eindhoven, Netherlands
Nijmegen, Netherlands
St. Petersburg 190089, Russian Federation
St. Petersburg 196084, Russian Federation
La Coruna, Spain
Cardiff, United Kingdom
Newcastle Upon Tyne, United Kingdom
San Juan de Alicante, Alicante, Spain
Badalona, Barcelona, Spain
Getafe, Madrid, Spain
Additional Information
Link to results on JAPIC
Starting date: March 2008
Last updated: March 4, 2013
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