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
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
601 Children's Lane
Norfolk, Virginia 23507
Norfolk, Virginia 23507
(757) 668-7000
![Children's Hospital of The King's Daughters](/wp-content/uploads/logos/children-s-hospital-of-the-king-s-daughters.gif)
Children's Hospital of The King's Daughters Children
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
![Oregon Health and Science University](/wp-content/uploads/logos/oregon-health-and-science-university.jpg)
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)
258 Calle San Jorge
San Juan, 00912
San Juan, 00912
Click here to add this to my saved trials
![](https://www.clinicaltrialsgps.com/wp-content/themes/GPS/media//img/tooltip-arrow.png)