NCT01598103

Safety and Efficacy of SAF312 in Patients With Neurogenic Detrusor Overactivity Due to Spinal Cord Lesions

A Multi-center, Double-blind, Randomized, Placebo-controlled, Cross-over Study to Evaluate the Efficacy, Safety and Tolerability of SAF312 in Subjects With Neurogenic Detrusor Overactivity Due to Spinal Cord Lesions Who Are Inadequately Managed by Antimuscarinic Therapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the safety, tolerability and efficacy of SAF312 in patients with overactive bladder disease due to spinal cord lesions. The overactive bladder of patients who qualify for this study is insufficiently managed by antimuscarinic therapy, or patients poorly tolerate the treatment with antimuscarinic drugs. The efficacy of SAF312 will be primarily determined via urodynamic measurements.

Conditions

• Neurogenic Urinary Bladder
• Neurogenic Bladder Disorder
• Neurogenic Dysfunction of the Urinary Bladder
• Neurogenic Bladder, Uninhibited
• Neurogenic Bladder, Spastic

Interventions

Type	Name	Description
DRUG	SAF312	One week of treatment in a BID (two times a day) regimen (hard gelatin capsules for oral use)
DRUG	Placebo to SAF312	One week of treatment in a BID (two times a day) regimen (hard gelatin capsules for oral use)

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2012-05-15
• Last updated: 2020-12-19

Locations

3 sites across 3 countries: Germany, Netherlands, Switzerland