At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 24-WEEK RANDOMIZED, OPEN-LABEL, STUDY TO EVALUATE THE SAFETY AND EFFICACY OF FESOTERODINE IN SUBJECTS AGED 6 TO 17 YEARS WITH SYMPTOMS OF DETRUSOR OVERACTIVITY ASSOCIATED WITH A NEUROLOGICAL CONDITION (NEUROGENIC DETRUSOR OVERACTIVITY)
In Brief
A Phase 3 clinical trial evaluating Fesoterodine PR 4 mg, Fesoterodine PR 8 mg, and 4 other interventions for Urinary Bladder, Neurogenic. Completed, enrolled 181 participants across 84 sites in 25 countries.
Detailed 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.
Study Details
Timeline
Interventions
Fesoterodine 4 mg tablet once daily for 24 weeks
Fesoterodine PR 8 mg tablet once daily for 24 weeks, the first week being 4 mg.
Fesoterodine 8 mg tablet once daily for 24 weeks, the first week being 4 mg.
Oxybutynin extended release tablets according to approved pediatric labeling for 12 weeks with dose titration phase for first 4 weeks to achieve dose optimisation.
Fesoterodine 4 mg or 8 mg tablets once daily for 12 weeks after 12 weeks of oxybutinin. Those assigned to 8 mg will take 4 mg for the first week.
Fesoterodine BIC 2 mg tablet once daily for 24 weeks.
Fesoterodine BIC 4 mg tablet once daily for 24 weeks, with the first week being 2 mg.