DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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


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 contraction

Change 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.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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


- 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


- 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


- 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017