NCT00629642

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 249 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis
• Neurogenic Bladder
• Spinal Cord Diseases

Interventions

Type	Name	Description
DRUG	Solifenacin Succinate	Oral, 10mg
DRUG	Solifenacin Succinate	Oral, 5mg
DRUG	Oxybutynin Hydrochloride	Oral, 15mg
DRUG	Placebo	Oral

Timeline

• Start date: 2008-03-14
• Primary completion: 2011-01-28
• Completion: 2011-01-28
• First posted: 2008-03-06
• Last updated: 2024-11-14

Locations

39 sites across 11 countries: Australia, Belgium, Czechia, France, Germany, Hungary, Italy, Netherlands, Russia, Spain, United Kingdom