Safety and Efficacy Evaluation of Oxybutynin Topical Gel In Children With Neurogenic Bladder



Status:Recruiting
Conditions:Other Indications, Overactive Bladder
Therapuetic Areas:Gastroenterology, Other
Healthy:No
Age Range:3 - 16
Updated:4/25/2018
Start Date:May 2, 2011
End Date:June 12, 2020
Contact:Clinical Trials Registry Team
Email:IR-CTRegistration@allergan.com
Phone:1-877-277-8566

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A Two-part, Multicenter, Dose-titration Study Evaluating Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of Oxybutynin Chloride 10% Gel for Treatment of Detrusor Overactivity Associated Neurological Condition in Pediatric Patients

This study will evaluate the safety and efficacy of Oxybutynin Chloride 10% Topical Gel in
children 3 to less than 17 years old, who have overactive bladder due to a neurogenic
condition. Children will be treated with 0.75 g of gel/day for two weeks. Patients will then
return to the clinic for a potential dose titration. At this time their dose may be adjusted
up to 1g/day, down to 0.5g/day, or remain the same at 0.75g of gel/day depending on the
individual response and tolerability. The total treatment time is 14 weeks and total time on
the study is 16 weeks.

This study will use a two-part, multicenter, dose-titration study in pediatric patients with
a detrusor overactivity associated with a neurological condition

Inclusion Criteria:

- 3 years to < 17 years

- Neurogenic bladder

- Neurological condition

- CIC

Exclusion Criteria:

- Have anatomical bladder abnormalities

- Sensitivity to anticholinergics

- Bladder augmentation
We found this trial at
16
sites
601 Children's Lane
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
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Norfolk, VA
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
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Charlotte, NC
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Jackson, MS
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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Orange, CA
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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Akron, OH
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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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Albany, NY
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Augusta, Georgia 30912
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Augusta, GA
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3901 Beaubien St
Detroit, Michigan 48201
(313) 745-5437
Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
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Detroit, MI
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Englewood, Colorado 80113
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Englewood, CO
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Houston, Texas 77030
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Houston, TX
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Loma Linda, California 92354
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Loma Linda, CA
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Long Beach, California
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Long Beach, CA
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Raleigh, North Carolina 27607
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Raleigh, NC
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San Juan,
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