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

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

A clinical study to evaluate the efficacy and safety of solifenacin in patients with bladder symptoms due to spinal cord injury or multiple sclerosis

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Spinal Cord Diseases; Neurogenic Bladder
• Intervention / Treatment: Drug: Placebo; Drug: Solifenacin Succinate; Drug: Solifenacin Succinate; Drug: Oxybutynin Hydrochloride

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.

• Study Type: Interventional
• Enrollment (Actual): 249
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • Brisbane, Australia
  • Melbourne, Australia
  • Perth, Australia
  • Randwick, Australia
• Belgium
  • Antwerpen, Belgium
  • Esneux, Belgium
  • Fraiture-en-Condroz, Belgium
  • Gent, Belgium
  • Leuven, Belgium
  • Melsbroek, Belgium
• Czechia
  • Brno, Czechia
  • Ceske Budejovice, Czechia
  • Prague, Czechia
• France
  • Caen, France
  • Garches, France
  • Paris, France
  • Ploemeur, France
• Germany
  • Berlin, Germany
  • Hagenow, Germany
  • Heidelberg, Germany
  • Kiel, Germany
• Hungary
  • Nyiregyhaza, Hungary
  • Sopron, Hungary
  • Szeged, Hungary
• Italy
  • Firenze, Italy
  • Milan, Italy
  • Rome, Italy
  • Torino, Italy
• Netherlands
  • Apeldoorn, Netherlands
  • Eindhoven, Netherlands
  • Nijmegen, Netherlands
• Russian Federation
  • St. Petersburg, Russian Federation, 196084
  • St. Petersburg, Russian Federation, 190089
• Spain
  • La Coruna, Spain
  • Alicante
    • San Juan de Alicante, Alicante, Spain
  • Barcelona
    • Badalona, Barcelona, Spain
  • Madrid
    • Getafe, Madrid, Spain
• United Kingdom
  • Cardiff, United Kingdom
  • Newcastle Upon Tyne, United Kingdom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: I.Solifenacin succinate 10mg (2x5mg 1/day); Oral	Drug: Solifenacin Succinate; Oral, 10mg; Other Names: Vesicare; YM905; Drug: Solifenacin Succinate; Oral, 5mg; Other Names: Vesicare; YM905
Experimental: II.Solifenacin succinate 5mg (5mg 1/day); Oral	Drug: Solifenacin Succinate; Oral, 10mg; Other Names: Vesicare; YM905; Drug: Solifenacin Succinate; Oral, 5mg; Other Names: Vesicare; YM905
Active Comparator: III.Oxybutynin hydrochloride 15mg (5mg 3/day); Oral	Drug: Oxybutynin Hydrochloride; Oral, 15mg
Placebo Comparator: IV. Placebo; Oral	Drug: Placebo; Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in maximum cystometric capacity	4 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in bladder volume at first involuntary contraction	4 Weeks
Change from baseline in pressure at first leak	4 Weeks
Change from baseline in volume at first leak	4 Weeks
Change from baseline in maximum detrusor pressure	4 Weeks
Change from baseline in micturition or catheterization frequency	4 Weeks
Change from baseline in incontinence episodes	4 Weeks
Incidence and severity of adverse events	4 Weeks

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Investigators: Principal Investigator: Department of (Neuro) Urology, Universitaire Ziekenhuizen KU Leuven

Publications and helpful links

Helpful Links

• Link to results on the Astellas Clinical Study Results website.

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2008
• Primary Completion (Actual): January 28, 2011
• Study Completion (Actual): January 28, 2011

Study Registration Dates

• First Submitted: February 26, 2008
• First Submitted That Met QC Criteria: February 27, 2008
• First Posted (Estimate): March 6, 2008

Study Record Updates

• Last Update Posted (Actual): September 1, 2017
• Last Update Submitted That Met QC Criteria: August 31, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Vesicare; Neurogenic bladder
• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Urologic Diseases; Urinary Bladder Diseases; Neurologic Manifestations; Multiple Sclerosis; Sclerosis; Spinal Cord Diseases; Urinary Bladder, Neurogenic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Oxybutynin; Solifenacin Succinate
• Other Study ID Numbers: 905-EC-005; 2006-005523-42 (Other Identifier: EudraCT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.