Trial document

PLEASE NOTE:
This study has been imported from ClinicalTrials.gov without additional data checks.

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DRKS-ID: DRKS00008822

Trial Description

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Title

Study of OnabotulinumtoxinA for Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Pediatric Patients

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This study will evaluate the safety and efficacy of onabotulinumtoxinA for the treatment of
urinary incontinence due to neurogenic detrusor overactivity in pediatric patients between
the ages of 8 to 17 years.

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Brief Summary in Scientific Language

[---]*

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Organizational Data

DRKS-ID: DRKS00008822
Date of Registration in DRKS: 2015/08/11
Date of Registration in Partner Registry or other Primary Registry: 2013/05/09
Investigator Sponsored/Initiated Trial (IST/IIT): no
Ethics Approval/Approval of the Ethics Committee: [---]*
(leading) Ethics Committee No.: [---]*

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Secondary IDs

EudraCT-No. (for studies acc. to Drug Law): 2012-004877-26
Primary Registry-ID: NCT01852045 (ClinicalTrials.gov)
Sponsor-ID: 191622-120 (Allergan)
Other Secondary-ID: 2012-004877-26

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Health Condition or Problem studied

Free text: Urinary Incontinence
ICD10: R32 - Unspecified urinary incontinence

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Interventions/Observational Groups

Arm 1: Biological: OnabotulinumtoxinA

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Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: Blinded
Who is blinded: patient/subject, caregiver, investigator/therapist, assessor
Control: [---]*
Purpose: Treatment
Assignment: Parallel
Phase: III
Off-label Drug use: [---]*

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Primary Outcome

- Change from Baseline in Daily Average Frequency of Daytime Urinary Incontinence Episodes; time frame: Baseline, 6 Weeks

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Secondary Outcome

- Change from Baseline in Maximum Cystometric Capacity (MCC); time frame: Baseline, Week 6
- Percentage of Patients With Involuntary Detrusor Contractions (IDC); time frame: Week 6
- Change from Baseline in Maximum Detrusor Pressure During the First IDC; time frame: Baseline, Week 6
- Change from Baseline in Detrusor Leak Point Pressure (DLPP); time frame: Baseline, Week 6
- Change from Baseline in Average Urine Volume at First Morning Catheterization; time frame: Baseline, 6 Weeks
- Percentage of Patients With Night Time Urinary Incontinence; time frame: 6 Weeks
- Change from Baseline in Maximum Detrusor Pressure; time frame: Baseline, Week 6
- Time to Patient Request for Retreatment; time frame: 48 Weeks
- Time to Patient Qualification for Retreatment; time frame: 48 Weeks

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Countries of Recruitment

US: United States
AT: Austria
BE: Belgium
CA: Canada
CZ: Czech Republic
FR: France
DE: Germany
IT: Italy
PL: Poland
TR: Turkey

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Locations of Recruitment

Berlin

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Recruitment

Planned/Actual: [---]*
(Anticipated or Actual) Date of First Enrollment: 2013/06/30
Target Sample Size: 132
Monocenter/Multicenter trial: Multicenter trial
National/International: International

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 8 Years
Maximum Age: 17 Years

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Additional Inclusion Criteria

- Urinary incontinence due to neurogenic detrusor overactivity

- Regularly using clean intermittent catheterization to empty the bladder

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Exclusion Criteria

- Surgery of the spinal cord within 6 months

- Diagnosis of cerebral palsy

- Current or planned use of a baclofen pump

- Current or planned use of an electrostimulation/neuromodulation device for urinary
incontinence

- Use of an indwelling catheter for urinary incontinence instead of using clean
intermittent catheterization to empty the bladder

- Previous or current use of botulinum toxin therapy of any serotype for any urological
condition, or treatment with botulinum toxin of any serotype within 3 months for any
other condition or use

- Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis

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Addresses

Primary Sponsor
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- Allergan
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Contact for Scientific Queries
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- Allergan
- Medical Director
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Contact for Public Queries
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- Allergan Inc.
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- Telephone: [---]*
- Fax: [---]*
- E-mail: clinicaltrials at allergan.com
- URL: [---]*
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Sources of Monetary or Material Support

[---]*
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- Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Status

Recruitment Status: Recruiting ongoing
Study Closing (LPLV): [---]*

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Trial Publications, Results and other Documents

Further trial documents: More information

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .

Translation on version: 3
Last processed date by ClinicalTrials.gov: 2016/01/14

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* This entry means the parameter is not applicable or has not been set.