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Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder

NCT00311376 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 416

Last updated 2015-12-04

Study results available
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Summary

The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A in treating overactive bladder in spinal cord injury or multiple sclerosis patients.

Conditions

Interventions

OTHER

Normal Saline (Placebo); botulinum toxin Type A (200U)

Placebo (tx 1) followed by botulinum toxin Type A 200 U (tx 2); injections into detrusor, at \> 12 weeks interval

OTHER

Normal Saline (Placebo); botulinum toxin Type A (300U)

Placebo (tx 1) followed by botulinum toxin Type A 300 U (tx 2), injections into detrusor, at \> 12 weeks interval

BIOLOGICAL

botulinum toxin Type A (200U)

botulinum toxin Type A 200 U (tx 1) followed by botulinum toxin Type A 200 U (tx 2); injections into detrusor, at \> 12 weeks interval

BIOLOGICAL

botulinum toxin Type A (300U)

botulinum toxin Type A 300 U (tx 1) followed by botulinum toxin Type A 300 U (tx 2); injections into detrusor, at \> 12 weeks interval

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • New Zealand
  • Poland
  • Russia
  • Slovakia
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT00311376 on ClinicalTrials.gov