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OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Overactive Bladder in Pediatric Patients (12 to 17)

Primary Purpose

Urinary Incontinence, Urinary Bladder, Overactive

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BOTOX®
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Symptoms of overactive bladder (OAB) (frequency/urgency) with urinary incontinence for at least 6 months
  • OAB symptoms not adequately managed by 1 or more anticholinergic agents

Exclusion Criteria

  • OAB caused by a neurological condition
  • Use of anticholinergics or other medications to treat OAB symptoms within 7 days
  • Current use of indwelling catheter or 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

Sites / Locations

  • Alaska Urological Institute /ID# 238189
  • Arkansas Children's Hospital /ID# 237787
  • Children's Hospital Colorado /ID# 237621
  • Yale New Haven Hospital - Yale School of Medicine /ID# 238222
  • Orlando Health-Arnold Palmer Hospital for Children Pediatric Urology /ID# 235283
  • Associated Urologist of North Carolina /ID# 235437
  • Cook Children's Med. Center /ID# 237539
  • Children's Hospital Wisconsin - Milwaukee Campus /ID# 237544
  • Sydney Children's Hospital /ID# 237191
  • The Children's Hospital at Westmead /ID# 234337
  • Monash Children's Hospital /ID# 234388
  • Universitair Ziekenhuis Antwerpen /ID# 237997
  • UZ Gent /ID# 237588
  • Universitair Ziekenhuis Leuven /ID# 237218
  • Alberta Children's Hospital /ID# 237510
  • London Health Sciences Center /ID# 234304
  • CHUS - Hopital Fleurimont /ID# 237668
  • Fakultni nemocnice Olomouc /ID# 237577
  • Duplicate_CHU Bordeaux-Hopital Pellegrin /ID# 237392
  • Hôpital de la Mère et de l'Enfant /ID# 235227
  • Hôpitaux Pédiatriques de Nice CHU-LENVAL /ID# 235278
  • Evangelisches Krankenhaus Bielefeld /ID# 235234
  • Urologische Gemeinschaftspraxis /ID# 234978
  • Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 234288
  • AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 237308
  • Radboud Universitair Medisch Centrum /ID# 237043
  • Maastricht Universitair Medisch Centrum /ID# 237678
  • Oslo University Hospital /ID# 234434
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu /ID# 238166
  • Specjalistyczny Gabinet Lekarski /ID# 235257
  • Medical Concierge Centrum Medyczne /ID# 235200
  • St Georges Hospital /ID# 235316
  • Manchester University NHS Foundation Trust /ID# 234380
  • Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 234819
  • NHS Greater Glasgow and Clyde /ID# 237430
  • NHS Grampian /ID# 237379
  • Alder Hey Children's NHS Foundation Trust /ID# 237279
  • Royal Berkshire NHS Foundation Trust /ID# 236915
  • Sheffield Children's NHS Foundation Trust /ID# 237854

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Botox 25 U

Botox 50 U

Botox 100 U

Arm Description

Participants randomized to receive 25 Units (U) BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone. Posttreatment follow-up clinic visits occurred at Weeks 2, 6, and 12. Participants could request retreatment from Week 12 and 12 weeks after each subsequent treatment for up to 4 cycles. The retreatment dose was determined by the Investigator and could be at the same dose or at the next higher dose compared with the preceding treatment.

Participants randomized to receive 50 Units (U) BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone. Posttreatment follow-up clinic visits occurred at Weeks 2, 6, and 12. Participants could request retreatment from Week 12 and 12 weeks after each subsequent treatment for up to 4 cycles. The retreatment dose was determined by the Investigator and could be at the same dose or at the next higher dose compared with the preceding treatment.

Participants randomized to receive 100 Units (U) BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone. Posttreatment follow-up clinic visits occurred at Weeks 2, 6, and 12. Participants could request retreatment from Week 12 and 12 weeks after each subsequent treatment for up to 4 cycles. The retreatment dose was determined by the Investigator and could be at the same dose or at the next higher dose compared with the preceding treatment.

Outcomes

Primary Outcome Measures

Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 1
Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime incontinence episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle.

Secondary Outcome Measures

Change From Study Baseline in the Daily Average Frequency of Normalized Daytime Micturition Episodes
Micturition was defined as toilet voids recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime micturition episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle.
Change From Study Baseline in the Daily Average Frequency of Normalized Daytime Urgency Episodes
Participants recorded daytime urgency episodes in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime urgency episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle.
Percentage of Participants With Night Time Urinary Incontinence
Urinary incontinence was defined as involuntary loss of urine. Participants recorded night time urinary incontinence episodes in a bladder diary during 2 consecutive days in the week prior to the study visit. Night time is defined as the time between going to bed to sleep for the night and waking up to start the next day. The number of daily night time urinary incontinence episodes were averaged during the 2-day period. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle.
Change From Study Baseline in the Daily Average Volume Voided Per Micturition (mL)
The volume per micturition was derived from the total urine volume voided over 1 daytime period during the 2-day bladder diary collection period divided by the number of voids in the same daytime period. Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. A negative change from Baseline indicates improvement. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle.
Change From Study Baseline in Pediatric Urinary Incontinence Quality of Life Total Score (PinQ)
The PinQ is a 20-item questionnaire that asks about the participant's incontinence and its consequences in daily life and relationships. Items are answered on a Likert-type scale of 0 (no) to 4 (all of the time) and a total sum score is calculated (from 0 to 80), with higher scores indicating lower health-related quality of life. A negative change from Baseline indicates improvement.
Change From Study Baseline in PinQ Item 'I am Worried That People Might Think my Clothes Smell Like Pee"
The Pediatric Urinary Incontinence Quality of (PinQ) is a 20-item questionnaire that asks about the participant's incontinence and its consequences in daily life and relationships. Items are answered on a Likert-type scale of 0 (no) to 4 (all of the time), with higher scores indicating lower health-related quality of life. A negative change from Baseline indicates improvement.
Change From Study Baseline in PinQ Item 'My Bladder Problem Makes me Feel Bad About Myself"
The Pediatric Urinary Incontinence Quality of (PinQ) is a 20-item questionnaire that asks about the participant's incontinence and its consequences in daily life and relationships. Items are answered on a Likert-type scale of 0 (no) to 4 (all of the time), with higher scores indicating lower health-related quality of life. A negative change from Baseline indicates improvement.
Change From Study Baseline in PinQ Item 'I Miss Out on Being With Friends Because of my Bladder Problems"
The Pediatric Urinary Incontinence Quality of (PinQ) is a 20-item questionnaire that asks about the participant's incontinence and its consequences in daily life and relationships. Items are answered on a Likert-type scale of 0 (no) to 4 (all of the time), with higher scores indicating lower health-related quality of life. A negative change from Baseline indicates improvement.
Percentage of Participants With a Positive Treatment Response in the Modified Treatment Benefit Scale
The Modified Treatment Benefit Scale (Modified TBS) is a single-item scale designed to assess the change in the participant's overactive bladder (OAB) condition following treatment. The participant's current condition (urinary problems, urinary incontinence) is compared to their condition prior to receipt of any study treatment by selection of "greatly improved", "improved", "not changed" or "worsened". Participants who selected "greatly improved" or "improved" were considered to have a positive treatment response.
Time to Participant's First Request for Retreatment
The time from the day of BOTOX treatment to the request for the subsequent treatment was estimated using a Kaplan-Meier survival method for each treatment group. Participants who did not request retreatment were treated as censored at the time of their last study visit or study exit.
Time to Participant's Qualification for Retreatment
The time from the day of BOTOX treatment to the qualification for retreatment was estimated using a Kaplan-Meier survival method for each treatment group. Participants who did not qualify for retreatment were treated as censored at the time of their last study visit or study exit.

Full Information

First Posted
March 24, 2014
Last Updated
November 23, 2022
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02097121
Brief Title
OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Overactive Bladder in Pediatric Patients (12 to 17)
Official Title
BOTOX® in the Treatment of Urinary Incontinence Due to Overactive Bladder in Patients 12 to 17 Years of Age
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Study Start Date
May 23, 2014 (Actual)
Primary Completion Date
February 10, 2022 (Actual)
Study Completion Date
February 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This was a multicenter, randomized, double-blind, parallel-group, multiple-dose study to evaluate the efficacy and safety of BOTOX in adolescents with urinary incontinence due to overactive bladder (OAB) with inadequate management with anticholinergic therapy. Participants were randomized in a 1:1:1 ratio to receive a single Tx of 25 U, 50 U, or 100 U BOTOX (not to exceed 6 U/kg) on Day 1, were seen after each treatment at Weeks 2, 6, and 12 post-treatment, and thereafter at alternating telephone and clinic visits every 6 weeks until they qualified for further retreatment/exited the study. Participants could receive multiple treatments dependent upon the number and timing of patient requests/qualification for retreatment. At each retreatment the investigator could keep the dose the same or increase it one dose level in a blinded fashion. Participants exited the study once 96 weeks have elapsed since entry on Day 1 and at least 12 weeks follow-up since their last study treatment had occurred.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Urinary Bladder, Overactive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Botox 25 U
Arm Type
Experimental
Arm Description
Participants randomized to receive 25 Units (U) BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone. Posttreatment follow-up clinic visits occurred at Weeks 2, 6, and 12. Participants could request retreatment from Week 12 and 12 weeks after each subsequent treatment for up to 4 cycles. The retreatment dose was determined by the Investigator and could be at the same dose or at the next higher dose compared with the preceding treatment.
Arm Title
Botox 50 U
Arm Type
Experimental
Arm Description
Participants randomized to receive 50 Units (U) BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone. Posttreatment follow-up clinic visits occurred at Weeks 2, 6, and 12. Participants could request retreatment from Week 12 and 12 weeks after each subsequent treatment for up to 4 cycles. The retreatment dose was determined by the Investigator and could be at the same dose or at the next higher dose compared with the preceding treatment.
Arm Title
Botox 100 U
Arm Type
Experimental
Arm Description
Participants randomized to receive 100 Units (U) BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone. Posttreatment follow-up clinic visits occurred at Weeks 2, 6, and 12. Participants could request retreatment from Week 12 and 12 weeks after each subsequent treatment for up to 4 cycles. The retreatment dose was determined by the Investigator and could be at the same dose or at the next higher dose compared with the preceding treatment.
Intervention Type
Biological
Intervention Name(s)
BOTOX®
Other Intervention Name(s)
Botulinum Toxin Type A
Intervention Description
Each vial of BOTOX (Botulinum Toxin Type A) purified neurotoxin complex, formulation No. 9060X contains 100 U of Clostridium botulinum toxin Type A, 0.5 mg albumin (human), and 0.9 mg sodium chloride in a sterile, vacuum-dried form without a preservative. The study medication was to be reconstituted with 0.9% sodium chloride (preservative-free). The 10 mL of study drug was to be administered as 20 injections each of 0.5 mL. Under direct cystoscopic visualization, injections were to be distributed evenly across the detrusor wall and spaced approximately 1 cm apart. To avoid injecting the trigone, the injections were to be at least 1 cm above the trigone. The injection needle was to be inserted approximately 2 mm into the detrusor for each injection.
Primary Outcome Measure Information:
Title
Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 1
Description
Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime incontinence episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle.
Time Frame
From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
Secondary Outcome Measure Information:
Title
Change From Study Baseline in the Daily Average Frequency of Normalized Daytime Micturition Episodes
Description
Micturition was defined as toilet voids recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime micturition episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle.
Time Frame
From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
Title
Change From Study Baseline in the Daily Average Frequency of Normalized Daytime Urgency Episodes
Description
Participants recorded daytime urgency episodes in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime urgency episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle.
Time Frame
From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
Title
Percentage of Participants With Night Time Urinary Incontinence
Description
Urinary incontinence was defined as involuntary loss of urine. Participants recorded night time urinary incontinence episodes in a bladder diary during 2 consecutive days in the week prior to the study visit. Night time is defined as the time between going to bed to sleep for the night and waking up to start the next day. The number of daily night time urinary incontinence episodes were averaged during the 2-day period. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle.
Time Frame
From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
Title
Change From Study Baseline in the Daily Average Volume Voided Per Micturition (mL)
Description
The volume per micturition was derived from the total urine volume voided over 1 daytime period during the 2-day bladder diary collection period divided by the number of voids in the same daytime period. Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. A negative change from Baseline indicates improvement. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle.
Time Frame
From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
Title
Change From Study Baseline in Pediatric Urinary Incontinence Quality of Life Total Score (PinQ)
Description
The PinQ is a 20-item questionnaire that asks about the participant's incontinence and its consequences in daily life and relationships. Items are answered on a Likert-type scale of 0 (no) to 4 (all of the time) and a total sum score is calculated (from 0 to 80), with higher scores indicating lower health-related quality of life. A negative change from Baseline indicates improvement.
Time Frame
From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1
Title
Change From Study Baseline in PinQ Item 'I am Worried That People Might Think my Clothes Smell Like Pee"
Description
The Pediatric Urinary Incontinence Quality of (PinQ) is a 20-item questionnaire that asks about the participant's incontinence and its consequences in daily life and relationships. Items are answered on a Likert-type scale of 0 (no) to 4 (all of the time), with higher scores indicating lower health-related quality of life. A negative change from Baseline indicates improvement.
Time Frame
From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1
Title
Change From Study Baseline in PinQ Item 'My Bladder Problem Makes me Feel Bad About Myself"
Description
The Pediatric Urinary Incontinence Quality of (PinQ) is a 20-item questionnaire that asks about the participant's incontinence and its consequences in daily life and relationships. Items are answered on a Likert-type scale of 0 (no) to 4 (all of the time), with higher scores indicating lower health-related quality of life. A negative change from Baseline indicates improvement.
Time Frame
From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1
Title
Change From Study Baseline in PinQ Item 'I Miss Out on Being With Friends Because of my Bladder Problems"
Description
The Pediatric Urinary Incontinence Quality of (PinQ) is a 20-item questionnaire that asks about the participant's incontinence and its consequences in daily life and relationships. Items are answered on a Likert-type scale of 0 (no) to 4 (all of the time), with higher scores indicating lower health-related quality of life. A negative change from Baseline indicates improvement.
Time Frame
From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1
Title
Percentage of Participants With a Positive Treatment Response in the Modified Treatment Benefit Scale
Description
The Modified Treatment Benefit Scale (Modified TBS) is a single-item scale designed to assess the change in the participant's overactive bladder (OAB) condition following treatment. The participant's current condition (urinary problems, urinary incontinence) is compared to their condition prior to receipt of any study treatment by selection of "greatly improved", "improved", "not changed" or "worsened". Participants who selected "greatly improved" or "improved" were considered to have a positive treatment response.
Time Frame
At Week 12 in Treatment Cycle 1
Title
Time to Participant's First Request for Retreatment
Description
The time from the day of BOTOX treatment to the request for the subsequent treatment was estimated using a Kaplan-Meier survival method for each treatment group. Participants who did not request retreatment were treated as censored at the time of their last study visit or study exit.
Time Frame
From the day of BOTOX treatment in Treatment Cycle 1 to the request for subsequent treatment
Title
Time to Participant's Qualification for Retreatment
Description
The time from the day of BOTOX treatment to the qualification for retreatment was estimated using a Kaplan-Meier survival method for each treatment group. Participants who did not qualify for retreatment were treated as censored at the time of their last study visit or study exit.
Time Frame
From the day of BOTOX treatment in Treatment Cycle 1 to the qualification for retreatment
Other Pre-specified Outcome Measures:
Title
Number of Participants With Treatment Emergent Adverse Events
Description
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Time Frame
From the first dose of study drug until the last dose, up to 147 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Symptoms of overactive bladder (OAB) (frequency/urgency) with urinary incontinence for at least 6 months OAB symptoms not adequately managed by 1 or more anticholinergic agents Exclusion Criteria OAB caused by a neurological condition Use of anticholinergics or other medications to treat OAB symptoms within 7 days Current use of indwelling catheter or 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ALLERGAN INC.
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Alaska Urological Institute /ID# 238189
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99503-3902
Country
United States
Facility Name
Arkansas Children's Hospital /ID# 237787
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Children's Hospital Colorado /ID# 237621
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale New Haven Hospital - Yale School of Medicine /ID# 238222
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510-3206
Country
United States
Facility Name
Orlando Health-Arnold Palmer Hospital for Children Pediatric Urology /ID# 235283
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Associated Urologist of North Carolina /ID# 235437
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Cook Children's Med. Center /ID# 237539
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Children's Hospital Wisconsin - Milwaukee Campus /ID# 237544
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Sydney Children's Hospital /ID# 237191
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
The Children's Hospital at Westmead /ID# 234337
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Monash Children's Hospital /ID# 234388
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Universitair Ziekenhuis Antwerpen /ID# 237997
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Facility Name
UZ Gent /ID# 237588
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitair Ziekenhuis Leuven /ID# 237218
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Alberta Children's Hospital /ID# 237510
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Facility Name
London Health Sciences Center /ID# 234304
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
CHUS - Hopital Fleurimont /ID# 237668
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Fakultni nemocnice Olomouc /ID# 237577
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Duplicate_CHU Bordeaux-Hopital Pellegrin /ID# 237392
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hôpital de la Mère et de l'Enfant /ID# 235227
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Hôpitaux Pédiatriques de Nice CHU-LENVAL /ID# 235278
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
Evangelisches Krankenhaus Bielefeld /ID# 235234
City
Bielefeld
ZIP/Postal Code
33617
Country
Germany
Facility Name
Urologische Gemeinschaftspraxis /ID# 234978
City
Emmendingen
ZIP/Postal Code
79312
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 234288
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 237308
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Facility Name
Radboud Universitair Medisch Centrum /ID# 237043
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Maastricht Universitair Medisch Centrum /ID# 237678
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Oslo University Hospital /ID# 234434
City
Oslo
ZIP/Postal Code
0372
Country
Norway
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu /ID# 238166
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Specjalistyczny Gabinet Lekarski /ID# 235257
City
Poznan
ZIP/Postal Code
61-512
Country
Poland
Facility Name
Medical Concierge Centrum Medyczne /ID# 235200
City
Warszawa
ZIP/Postal Code
02-798
Country
Poland
Facility Name
St Georges Hospital /ID# 235316
City
Port Elizabeth
ZIP/Postal Code
6001
Country
South Africa
Facility Name
Manchester University NHS Foundation Trust /ID# 234380
City
Manchester
State/Province
Lancashire
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 234819
City
Norwich
State/Province
Norfolk
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
NHS Greater Glasgow and Clyde /ID# 237430
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 0XH
Country
United Kingdom
Facility Name
NHS Grampian /ID# 237379
City
Aberdeen
ZIP/Postal Code
AB15 6RE
Country
United Kingdom
Facility Name
Alder Hey Children's NHS Foundation Trust /ID# 237279
City
Liverpool
ZIP/Postal Code
L12 2AP
Country
United Kingdom
Facility Name
Royal Berkshire NHS Foundation Trust /ID# 236915
City
Reading
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
Facility Name
Sheffield Children's NHS Foundation Trust /ID# 237854
City
Sheffield
ZIP/Postal Code
S10 2TH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
http://www.allerganclinicaltrials.com
Description
Additional information on study locations near you may be found at AllerganClinicalTrials.com.,To be considered as a site for current and future Allergan Clinical Trials, please register using the Investigator Databank link.

Learn more about this trial

OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Overactive Bladder in Pediatric Patients (12 to 17)

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