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Trial record 80 of 724 for:    Botulinum Toxins, Type A

A Safety and Efficacy Study of Botulinum Toxin Type A (BOTOX®) to Treat Urinary Incontinence Due to Neurogenic Detrusor Overactivity or Overactive Bladder in Korean Patients

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ClinicalTrials.gov Identifier: NCT02601287
Recruitment Status : Completed
First Posted : November 10, 2015
Last Update Posted : July 21, 2016
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
This is a safety and efficacy study of BOTOX® (Botulinum Toxin Type A) in the Treatment of Adult Korean Patients with Urinary Incontinence due to Neurogenic Detrusor Overactivity or Overactive Bladder.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Overactive Bladder Biological: Botulinum Toxin Type A Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BOTOX® 100U
Botulinum Toxin Type A 100U into the detrusor muscle on Day 1 in patients with Overactive Bladder
Biological: Botulinum Toxin Type A
Botulinum Toxin Type A into detrusor muscle on Day 1
Other Names:
  • BOTOX®
  • onabotulinumtoxinA

Experimental: BOTOX® 200U
Botulinum Toxin Type A 200U into the detrusor muscle on Day 1 in patients with Neurogenic Detrusor Overactivity
Biological: Botulinum Toxin Type A
Botulinum Toxin Type A into detrusor muscle on Day 1
Other Names:
  • BOTOX®
  • onabotulinumtoxinA




Primary Outcome Measures :
  1. Change from the baseline in the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) total score [ Time Frame: Baseline, Day 28 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis
  • Symptoms of urge urinary incontinence, urgency, and frequency due to overactive bladder

Exclusion Criteria:

  • Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
  • Use of botulinum toxin therapy of any serotype in the 3 months prior to screening
  • Has acute urinary retention who do not routinely perform clean intermittent self-catheterization (CIC)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02601287


Locations
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Korea, Republic of
Pusan National University Hospital
Busan, Korea, Korea, Republic of, 49241
The Catholic University of Korea Bucheion St. Mary Hospital
Gyeonggi-do, Korea, Korea, Republic of, 14647
Seoul National University Hospital
Seoul, Korea, Korea, Republic of, 03080
Asan Medical Center
Seoul, Korea, Korea, Republic of, 05505
Samsung Medical Center
Seoul, Korea, Korea, Republic of, 06351
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Contact Allergan

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02601287     History of Changes
Other Study ID Numbers: 191622-151
First Posted: November 10, 2015    Key Record Dates
Last Update Posted: July 21, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
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Botulinum Toxins
Botulinum Toxins, Type A
Urinary Incontinence
Enuresis
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Urinary Bladder Diseases
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents