Phase 3
Completed N=181
A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition
Urinary Bladder, Neurogenic
Source: ClinicalTrials.gov NCT01557244 ↗
Enrolled (actual)
181
Serious AEs
4.2%
Results posted
Feb 2021
Primary outcomePrimary: Change From Baseline in Maximum Cystometric Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase — 58.12; 83.36; 87.17; 23.49 milliliter — p=0.0001
◆ Published Evidence
Emerging
4citations · ~1 / year
Fesoterodine treatment of pediatric patients with neurogenic detrusor overactivity: A 24-week, randomized, open-label, phase 3 study.
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.
Linked Publications (2)
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Fesoterodine treatment of pediatric patients with neurogenic detrusor overactivity: A 24-week, randomized, open-label, phase 3 study.
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Population Pharmacokinetic and Pharmacodynamic Modeling of Fesoterodine in Pediatric Patients with Neurogenic Detrusor Overactivity.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Maximum Cystometric Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase |
58.12; 83.36; 87.17; 23.49; 40.17 | 0.0001 sig |
| SECONDARY Change From Baseline in Detrusor Pressure at Maximum Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase |
-2.86; -1.57; -2.39; -2.74; -9.73 | 0.2334 |
| SECONDARY Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase |
12; 4; 6; 0; 1; 2 | — |
| SECONDARY Change From Baseline in Bladder Volume at First Involuntary Detrusor Contraction (IDC) at Week 12: Active Comparator Phase/Efficacy Phase |
30.53; 26.06; 41.31; 23.80; 31.26 | 0.0336 sig |
| SECONDARY Change From Baseline in Bladder Compliance at Week 12: Active Comparator Phase/Efficacy Phase |
6.40; 5.41; 11.36; 12.44; 16.44 | 0.0679 |
| SECONDARY Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase |
-1.07; -0.68; -0.97; -0.37; -0.70 | 0.0116 sig |
| SECONDARY Change From Baseline in Mean Number of Catheterizations Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase |
-0.30; -0.32; -0.34; -0.10; -0.22 | 0.0787 |
| SECONDARY Change From Baseline in Mean Number of Micturitions or Catheterizations Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase |
-0.61; -0.60; -0.75; -0.24; -0.28 | 0.0111 sig |
| SECONDARY Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase |
-0.46; -0.89; -1.01; -0.38; -0.69 | 0.0496 sig |
| SECONDARY Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase |
-0.62; -0.50; -0.14; -0.23; -0.62 | 0.0298 sig |
| SECONDARY Change From Baseline in Mean Volume Voided Per Micturition at Week 12: Active Comparator Phase/Efficacy Phase |
4.10; 19.21; 4.15; -12.72; -8.41 | 0.7986 |
| SECONDARY Change From Baseline in Mean Volume Voided Per Catheterization at Week 12: Active Comparator Phase/Efficacy Phase |
29.47; 47.18; 45.90; 11.50; 1.74 | 0.0610 |
| SECONDARY Change From Baseline in Mean Volume Voided Per Micturition or Catheterization at Week 12: Active Comparator Phase/Efficacy Phase |
18.45; 55.55; 36.69; 7.12; -2.65 | 0.2246 |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Active Comparator Phase/Efficacy Phase |
26; 20; 30; 19; 18; 3 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Safety Extension Phase |
14; 13; 9; 11; 11; 16 | — |
| SECONDARY Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase |
0.09; 0.11; 0.03; 0.15; 0.10; 0.01 | — |
| SECONDARY Change From Baseline in Visual Acuity at Week 24: Safety Extension Phase |
0.04; -0.02; -0.01; 0.02; 0.00; 0.01 | — |
| SECONDARY Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase |
11.88; 15.94; 9.59; 9.67; 8.17; 1.74 | — |
| SECONDARY Change From Baseline in Visual Accommodation at Week 24: Safety Extension Phase |
0.73; 4.33; 1.50; 0.50; -1.35; 0.96 | — |
| SECONDARY Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase |
53.86; 54.32; 54.58; 54.9; 52.8; -1.03 | — |
| SECONDARY Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase |
-1.59; -1.31; -1.25; -2.40; -1.70; -1.86 | — |
| SECONDARY Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase |
4.19; 4.66; 4.88; 5.1; 3.5; -0.62 | — |
| SECONDARY Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase |
-1.34; -1.17; -0.81; -1.75; -1.40; -1.57 | — |
| SECONDARY Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase |
61.11; 56.50; 46.43; 69.56; 52.20; -7.71 | — |
| SECONDARY Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase |
-11.33; -3.71; -2.00; -6.33; -7.07; -15.00 | — |
| SECONDARY Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase |
88.85; 92.15; 82.64; 106.7; 124.7; -5.40 | — |
| SECONDARY Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase |
-8.20; -12.27; -5.71; -7.00; -38.20; -17.00 | — |
| SECONDARY Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase |
0.11; 0.75; 0.29; 0.39; 0.10; 0.29 | — |
| SECONDARY Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase |
0.33; 0.43; 0.00; -0.33; -0.27; -0.06 | — |
| SECONDARY Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase |
0.45; 0.24; 0.24; 0.10; 0.11; 0.00 | — |
| SECONDARY Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase |
0.00; 0.63; 0.14; 0.25; 0.00; 0.44 | — |
| SECONDARY Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase |
9.56; 9.38; 10.00; 9.89; 10.0; -0.29 | — |
| SECONDARY Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase |
-0.33; 0.00; 0.00; 0.00; 0.07; 0.00 | — |
| SECONDARY Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase |
25.00; 24.56; 25.00; 25.00; 23.22; -0.07 | — |
| SECONDARY Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase |
0.00; 0.50; 0.00; 0.00; 0.00; 0.11 | — |
| SECONDARY Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase |
2; 2; 0; 7; 4; 1 | — |
| SECONDARY Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase |
0; 3; 2; 1; 4; 2 | — |
| SECONDARY Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Active Comparator/Efficacy Phase |
4; 1; 4; 3; 4 | — |
| SECONDARY Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Safety Extension Phase |
0; 1; 2; 0; 1; 5 | — |
| SECONDARY Number of Participants With Clinical Laboratory Abnormalities: Active Comparator/Efficacy Phase |
30; 29; 27; 19; 19 | — |
| SECONDARY Number of Participants With Clinical Laboratory Abnormalities: Safety Extension Phase |
19; 22; 7; 12; 15; 21 | — |
| SECONDARY Change From Baseline in Post-Void Residual (PVR) Volume at Weeks 4, 12: Active Comparator Phase/Efficacy Phase |
7.00; 9.57; 5.78; 14.7; 10.7; 5.40 | — |
| SECONDARY Change From Baseline in Post-Void Residual Volume at Week 24: Safety Extension Phase |
11.50; 11.60; 18.00; 36.67; 21.67; 2.75 | — |
| SECONDARY Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 12: Active Comparator/Efficacy Phase |
2; 1; 1; 1; 0 | — |
| SECONDARY Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 24: Safety Extension Phase |
3; 2; 0; 0; 0; 2 | — |
| SECONDARY Absorption Rate Constant (Ka) of Fesoterodine |
0.0897 | — |
| SECONDARY Apparent Oral Clearance (CL/F) of Fesoterodine |
71.6 | — |
| SECONDARY Volume of Distribution (Vd) of Fesoterodine |
68.1 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects aged 6 to 17 years old
- Subjects with stable neurological disease and neurogenic detrusor overactivity
- Subjects using clean intermittent catheterization may participate
Exclusion Criteria
- Concomitant medications which may increase the risk to subjects or confound study results
- Other medical conditions which may increase the risk to subjects or confound study results
- Contraindications to the use of fesoterodine or oxybutynin
Data sourced from ClinicalTrials.gov (NCT01557244) and the linked publication. 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.