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 |
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.
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
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
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University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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601 Children's Lane
Norfolk, Virginia 23507
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
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Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
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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Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
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258 Calle San Jorge
San Juan, 00912
San Juan, 00912
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