Trials / Completed
CompletedNCT01557244
A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 181 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 6 Years – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fesoterodine PR 4 mg | Fesoterodine 4 mg tablet once daily for 24 weeks |
| DRUG | Fesoterodine PR 8 mg | Fesoterodine PR 8 mg tablet once daily for 24 weeks, the first week being 4 mg. |
| DRUG | Fesoterodine PR 8 mg | Fesoterodine 8 mg tablet once daily for 24 weeks, the first week being 4 mg. |
| DRUG | Oxybutynin | Oxybutynin extended release tablets according to approved pediatric labeling for 12 weeks with dose titration phase for first 4 weeks to achieve dose optimisation. |
| DRUG | Fesoterodine PR | 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. |
| DRUG | Fesoterodine BIC 2 mg | Fesoterodine BIC 2 mg tablet once daily for 24 weeks. |
| DRUG | Fesoterodine BIC 4 mg | Fesoterodine BIC 4 mg tablet once daily for 24 weeks, with the first week being 2 mg. |
Timeline
- Start date
- 2012-07-02
- Primary completion
- 2019-11-07
- Completion
- 2020-02-13
- First posted
- 2012-03-19
- Last updated
- 2021-02-02
- Results posted
- 2021-02-02
Locations
84 sites across 25 countries: United States, Belgium, Canada, Estonia, Finland, France, Germany, Greece, India, Italy, Japan, Lithuania, Malaysia, Philippines, Poland, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01557244. Inclusion in this directory is not an endorsement.