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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00910520
Other study ID # 191622-520
Secondary ID
Status Completed
Phase Phase 3
First received May 28, 2009
Last updated January 29, 2013
Start date September 2009
Est. completion date August 2011

Study information

Verified date January 2013
Source Allergan
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A (onabotulinumtoxinA) in treating patients with idiopathic overactive bladder with urinary incontinence.


Recruitment information / eligibility

Status Completed
Enrollment 548
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Symptoms of OAB (frequency/urgency) with urinary incontinence for at least 6 months

- Inadequate response or limiting side effects with anticholinergics for the treatment of OAB

Exclusion Criteria:

- Overactive Bladder caused by neurological condition

- Patient has predominance of stress incontinence

- History or evidence of pelvic or urological abnormality

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
onabotulinumtoxinA
OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable). Or, if placebo is administered at Day 1, onabotulinumtoxinA 100 U injected after a minimum of 12 weeks (if applicable).
Drug:
normal saline
Normal saline (placebo) injected into the detrusor at Day 1.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Belgium,  Czech Republic,  Germany,  Poland,  Russian Federation,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline in Number of Daily Episodes of Urinary Incontinence A urinary incontinence episode is defined as an incident of involuntary loss of urine as recorded in a patient bladder diary during the 3 days before the Baseline and Week 12 study visits. A negative number change from baseline indicates a reduction in incontinence episodes (improvement). Baseline, Week 12 No
Secondary Change From Baseline in Number of Daily Micturition Episodes The number of micturition episodes (the number of times a patient urinates into the toilet) was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the Baseline and prior to the Week 12 study visit. A negative number change from baseline indicates a reduction in micturition episodes (improvement). Baseline, Week 12 No
Secondary Change From Baseline in Volume Voided Per Micturition The total volume voided was measured over one 24-hour period in the week prior to the Baseline and Week 12 study visit and recorded by the patient in the bladder diary. This was used to calculate volume voided per micturition. A positive number change from baseline indicates an increase in volume voided per micturition (improvement). Baseline, Week 12 No
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