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

NCT01598103 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2020-12-19

No results posted yet for this study

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

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)

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • Germany
  • Netherlands
  • Switzerland

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01598103 on ClinicalTrials.gov