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Comparative Study of the Efficacy and Safety of Muscarinic M3 Receptors Antagonists in the Treatment of Neurogenic Detrusor Overactivity

NCT00800462 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2013-04-08

No results posted yet for this study

Summary

This is a phase IV, double-blind, multicenter, randomized trial evaluating the efficacy and safety of two M3 receptors antagonists (Trospium Chloride and Darifenacin Hydrobromide) with one standard drug (Oxybutynin Chloride) for treatment of overactive bladder in individuals with spinal cord injury.

Conditions

  • Spinal Cord Injury
  • Neurogenic Detrusor Overactivity

Interventions

DRUG

Oxybutynin Cl

15 mg qd for 3 months

DRUG

Trospium Cl

20mg bid for 3 months

DRUG

Darifenacin Hydrogen Bromide (HBr)

15 mg qd for 3 months

Sponsors & Collaborators

  • Ontario Neurotrauma Foundation

    collaborator OTHER

  • Toronto Rehabilitation Institute

    lead OTHER

Principal Investigators

  • Magdy Hassouna, MD · Toronto Rehabilitation Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2012-06-30
Completion
2012-12-31

Countries

  • Canada

Study Locations

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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 NCT00800462 on ClinicalTrials.gov