Phase 2
Completed N=21
Study Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years
Overactive Bladder · Neurogenic Detrusor Overactivity
Source: ClinicalTrials.gov NCT00857896 ↗
Enrolled (actual)
21
Serious AEs
2.4%
Results posted
Nov 2011
Primary outcomePrimary: Absorption Rate Constant (Ka) — 0.44 1/hour (hr)
Summary
The purpose of the study is to evaluate the pharmacokinetics, safety, and tolerability of fesoterodine following administration to pediatric patients, aged 8-17 years, with overactive bladder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absorption Rate Constant (Ka) |
0.44 | — |
| PRIMARY Apparent Volume of Distribution (VC/F) |
1010.00 | — |
| PRIMARY Area Under the Plasma Drug Concentration Time Curve (AUC) |
— | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
— | — |
| PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
— | — |
| PRIMARY Plasma Decay Half-Life (t1/2) |
— | — |
| PRIMARY Apparent Oral Clearance (CL/F) |
86.70 | — |
| SECONDARY Post-void Residual (PVR) Volume |
6.00; 4.00; 25.00 | — |
Eligibility Criteria
Inclusion Criteria
- A total body weight >25 kg (55 lbs).
- Symptoms of urinary frequency (average ≥8 daily bathroom visits to urinate) and urgency to urinate, with or without urgency incontinence, for at least 6 months prior to enrolment, OR
- Stable neurological disease and urodynamically confirmed detrusor overactivity, who may require intermittent catheterization for management of urinary drainage.
Exclusion Criteria
- Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is longer, before first study dose
- Ongoing use of potent CYP3A4 inhibitors or inducers or CYP2D6 inhibitors
- Ongoing use of another drug for treating overactive bladder
- Uncontrolled narrow angle glaucoma, urinary or gastric retention
Data sourced from ClinicalTrials.gov (NCT00857896). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.