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

NCT00575016 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2015-10-02

Study results available
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Summary

The purpose of this study is to explore the effectiveness and safety of several doses of botulinum toxin type A in treating overactive bladder in patients with spinal cord injury.

Conditions

Interventions

BIOLOGICAL

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

Placebo injection on Day 1 and botulinum toxin Type A injection 200 U \> Week 12; injection into the detrusor

BIOLOGICAL

botulinum toxin Type A (50U); botulinum toxin Type A (200U)

botulinum toxin Type A 50 U on Day 1 followed by botulinum toxin Type A 200 U \> 12 weeks; injections into the detrusor

BIOLOGICAL

botulinum toxin Type A (100U); botulinum toxin Type A (200U)

botulinum toxin Type A 100 U on Day 1 followed by botulinum toxin Type A 200 U \> 12 weeks; injections into the detrusor

BIOLOGICAL

botulinum toxin Type A (200U)

botulinum toxin Type A 200 U on Day 1 followed by botulinum toxin Type A 200 U \> 12 weeks; injections into the detrusor

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
2007-12-31
Primary Completion
2010-02-28
Completion
2010-07-31

Countries

  • Egypt
  • Greece
  • India
  • Lebanon
  • Serbia
  • Turkey (Türkiye)

Study Locations

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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 NCT00575016 on ClinicalTrials.gov