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COMPLETEDPHASE4

Clinical Study of Solifenacin Succinate in Patients With Bladder Symptoms Due to Spinal Cord Injury or Multiple Sclerosis

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

NCT00629642•Astellas Pharma Inc

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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
+10 more criteria

Locations (39)

Brisbane, Australia

Melbourne, Australia

Perth, Australia

Randwick, Australia

Antwerp, Belgium

Esneux, Belgium

Fraiture-en-Condroz, Belgium

Ghent, Belgium

Leuven, Belgium

Melsbroek, Belgium

Key Dates

Start Date

March 14, 2008

Primary Completion Date

January 28, 2011

Completion Date

January 28, 2011

Last Updated

November 14, 2024

Enrollment

249

ACTUAL participants

Conditions

Multiple SclerosisNeurogenic BladderSpinal Cord Diseases

Interventions

Solifenacin Succinate

DRUG

Solifenacin Succinate

DRUG

Oxybutynin Hydrochloride

DRUG

Placebo

DRUG

Intermittent Hypoxia in Persons With Multiple Sclerosis

NCT06276634

Multiple SclerosisMultiple Sclerosis-Relapsing-Remitting+1 more

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RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

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Secondary Progressive Multiple Sclerosis (SPMS)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 14, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Study of Solifenacin Succinate in Patients With Bladder Symptoms Due to Spinal Cord Injury or Multiple Sclerosis

Inclusion Criteria

Exclusion Criteria

Intermittent Hypoxia in Persons With Multiple Sclerosis

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

Assess the Efficacy of OM-89 vs Placebo in Reducing Antibiotic Consumption Associated With the Treatment of Urinary Tract Infections in Patients With Neurogenic Bladder

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