drugset / Trial / NCT01557244
A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition
RandomizedParallel-groupOpen-labelTreatment
Summary
The objective of the study is to find out if the medicine fesoterodine is a useful treatment in children with bladder muscle overactivity caused by a neurological condition. Children will be aged 6 to 17 years old. This is done by finding out how well it works, what the body does to fesoterodine, what side effects are experienced and the safety of fesoterodine. It will be compared with the medicine oxybutynin, which is already available for treating the condition.
Timeline
- Start
- 2012-07-02
- Primary completion
- 2019-11-07
- Completion
- 2020-02-13
Publications
- Sano Y, Shoji S, Shahin M, Sweeney K, Darekar A, Malhotra BK. Population Pharmacokinetic and Pharmacodynamic Modeling of Fesoterodine in Pediatric Patients with Neurogenic Detrusor Overactivity. Eur J Drug Metab Pharmacokinet. 2023 May;48(3):257-269. doi: 10.1007/s13318-023-00818-8. Epub 2023 Mar 9.
- Kitta T, Darekar A, Malhotra B, Shahin MH, Jones P, Lindsay M, Mallen S, Nieto A, Crook TJ. Fesoterodine treatment of pediatric patients with neurogenic detrusor overactivity: A 24-week, randomized, open-label, phase 3 study. J Pediatr Urol. 2023 Apr;19(2):175.e1-175.e10. doi: 10.1016/j.jpurol.2022.11.020. Epub 2022 Nov 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fesoterodine | Other / unclassified | 2 mg | — |
| Subject | Fesoterodine | Other / unclassified | 4 mg | — |
| Subject | Fesoterodine | Other / unclassified | 8 mg | — |
| Comparator | Oxybutynin | Small molecule | — | — |