Clinical trial NCT00629642: Clinical Study of Solifenacin Succinate in Patients With Bladder Symptoms Due to Spinal Cord Injury or Multiple Sclerosis
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis
Neurogenic Bladder
Spinal Cord Diseases
Keywords: Neurogenic bladder
Vesicare
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-03-06
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline in maximum cystometric capacity
timeFrame: 4 Weeks
Secondary outcomes:
measure: Change from baseline in bladder volume at first involuntary contraction
timeFrame: 4 Weeks
measure: Change from baseline in pressure at first leak
timeFrame: 4 Weeks
measure: Change from baseline in volume at first leak
timeFrame: 4 Weeks
measure: Change from baseline in maximum detrusor pressure
timeFrame: 4 Weeks
measure: Change from baseline in micturition or catheterization frequency
timeFrame: 4 Weeks
measure: Change from baseline in incontinence episodes
timeFrame: 4 Weeks
measure: Incidence and severity of adverse events
timeFrame: 4 Weeks
Other outcomes:
Locations:
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
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: San Juan de Alicante
country: Spain
state: Alicante
city: Badalona
country: Spain
state: Barcelona
city: Getafe
country: Spain
state: Madrid
city: La Coruna
country: Spain
city: Cardiff
country: United Kingdom
city: Newcastle Upon Tyne
country: United Kingdom
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Department of (Neuro) Urology
role: PRINCIPAL_INVESTIGATOR
References: