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Trial record 1 of 1 for:    Allergan GMA-OAB-113
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OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder (COMFORT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01945489
First received: September 16, 2013
Last updated: May 15, 2017
Last verified: May 2017
  Purpose
This is a study to evaluate the efficacy and safety of onabotulinumtoxinA (BOTOX®) compared with placebo, in achieving a 100% reduction in urinary incontinence in patients with overactive bladder (OAB) not properly managed with an anticholinergic.

Condition Intervention Phase
Overactive Bladder Biological: onabotulinumtoxinA Drug: Normal saline Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Participants who Achieve a 100% Reduction in Urinary Incontinence Episodes [ Time Frame: Baseline, Week 12 ]
  • Change from Baseline in Number of Episodes of Urinary Incontinence [ Time Frame: Baseline, Week 12 ]

Secondary Outcome Measures:
  • King's Health Questionnaire (KHQ) domain scores [ Time Frame: Week 12 ]
  • Number of Micturition Episodes [ Time Frame: Week 12 ]
  • Number of Daily Urgency Episodes [ Time Frame: Week 12 ]
  • Number of Nocturia Episodes [ Time Frame: Week 12 ]

Enrollment: 254
Actual Study Start Date: October 28, 2013
Study Completion Date: January 5, 2017
Primary Completion Date: May 24, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OnabotulinumtoxinA
OnabotulinumtoxinA (BOTOX®) 100U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
Biological: onabotulinumtoxinA
OnabotulinumtoxinA (BOTOX®) injected into the detrusor.
Other Names:
  • BOTOX®
  • botulinum toxin Type A
Placebo/OnabotulinumtoxinA
Placebo (Normal saline) injected into the detrusor on Day 1, followed by an injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
Biological: onabotulinumtoxinA
OnabotulinumtoxinA (BOTOX®) injected into the detrusor.
Other Names:
  • BOTOX®
  • botulinum toxin Type A
Drug: Normal saline
Normal saline (placebo) injected into the detrusor.

  Eligibility

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

Inclusion Criteria:

-Patients with symptoms of Overactive Bladder (OAB) (frequency and urgency) with urinary incontinence for at least 6 months prior to screening.

Exclusion Criteria:

  • Symptoms of OAB due to a neurological reason
  • Use of anticholinergics or other medications or therapies to treat symptoms of OAB within 7 days of screening
  • Use of Clean Intermittent Catheterization (CIC) or indwelling catheter to manage urinary incontinence
  • Use of botulinum toxin therapy of any serotype for any urological condition
  • Use of botulinum toxin therapy of any serotype for any non-urological condition in the 12 weeks prior to screening
  • History of any pelvic or urological abnormalities, bladder surgery or disease, other than OAB, that may affect bladder function
  • Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, or Amyotrophic Lateral Sclerosis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01945489

  Show 40 Study Locations
Sponsors and Collaborators
Allergan
Investigators
Study Director: Tamer Aboushwareb Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01945489     History of Changes
Other Study ID Numbers: GMA-OAB-113
Study First Received: September 16, 2013
Last Updated: May 15, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Incontinence
Enuresis
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Urination Disorders
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
onabotulinumtoxinA
incobotulinumtoxinA
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

ClinicalTrials.gov processed this record on June 26, 2017