Phase 3
N=12
Open-label Long-term Extension Study of Fesoterodine in Japanese Subjects With Neurogenic Detrusor Overactivity.
Urinary Bladder, Neurogenic
Bottom Line
View on ClinicalTrials.gov: NCT02501928 ↗Enrolled (actual)
12
Serious AEs
8.3%
Results posted
Oct 2020
Primary outcome: Primary: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Merged Data of Studies A0221047 and A0221109 — 2; 9; 2; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fesoterodine PR 4 mg (Drug); Fesoterodine PR 8 mg (Drug); Fesoterodine BIC 2 mg (Drug); Fesoterodine BIC 4 mg (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Merged Data of Studies A0221047 and A0221109 |
2; 9; 2; 6; 3; 11 | — |
| PRIMARY Change From Baseline in Visual Acuity at Week 12: Study A0221109 |
0.27; 0.04; 0.28; 0.14; -0.03; 0.04 | — |
| PRIMARY Change From Baseline in Visual Acuity at Week 28: Study A0221109 |
0.00; 0.03; 0.02; 0.31; 0.05; 0.16 | — |
| PRIMARY Change From Baseline in Visual Acuity at Final Visit: Study A0221109 |
0.00; 0.02; 0.02; 0.31; 0.04; 0.16 | — |
| PRIMARY Change From Baseline in Visual Accommodation at Week 12: Study A0221109 |
9.33; 8.62; 5.56; 2.50; 5.86; 6.67 | — |
| PRIMARY Change From Baseline in Visual Accommodation at Week 28: Study A0221109 |
5.17; 0.78; -0.11; 3.17; -0.39; 0.50 | — |
| PRIMARY Change From Baseline in Visual Accommodation at Final Visit: Study A0221109 |
5.17; 4.38; -0.11; 3.17; 2.86; 0.50 | — |
| PRIMARY Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Study A0221109 |
50.0; 52.6; 50.7; 0.0; -0.1; 0.0 | — |
| PRIMARY Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 28: Study A0221109 |
0.0; -2.2; -0.3; 0.0; -0.7; 0.3 | — |
| PRIMARY Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Final Visit: Study A0221109 |
0.0; -1.9; -0.3; 0.0; -0.6; 0.3 | — |
| PRIMARY Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 12: Study A0221109 |
0.0; 3.4; 2.0; 0.0; -0.1; 0.0 | — |
| PRIMARY Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 28: Study A0221109 |
0.0; -1.8; -0.3; 0.0; -0.3; 0.0 | — |
| PRIMARY Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Final Visit: Study A0221109 |
0.0; -1.6; -0.3; 0.0; -0.3; 0.0 | — |
| PRIMARY Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Time to Completion: Study A0221109 |
43.0; 39.3; 0.8; -0.3; 33.4; 52.0 | — |
| PRIMARY Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 28- Time to Completion: Study A0221109 |
4.5; 3.7; 6.3; -7.7 | — |
| PRIMARY Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Final Visit- Time to Completion: Study A0221109 |
0.8; 3.7; 4.4; -7.7 | — |
| PRIMARY Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Time to Completion: Study A0221109 |
59.5; 107.5; 0.0; -11.5; 60.5; 145.5 | — |
| PRIMARY Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 28- Time to Completion: Study A0221109 |
2.0; -14.0; -1.0; -35.0 | — |
| PRIMARY Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Final Visit- Time to Completion: Study A0221109 |
2.08; -14.0; -1.0; -35.0 | — |
| PRIMARY Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Number of Pegs Dropped: Study A0221109 |
0.2; 0.0; 0.2; 0.0; 0.0; 0.0 | — |
| PRIMARY Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 28- Number of Pegs Dropped: Study A0221109 |
0.3; 0.0; 0.0; 0.0 | — |
| PRIMARY Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Final Visit- Number of Pegs Dropped: Study A0221109 |
0.2; 0.0; 0.0; 0.0 | — |
| PRIMARY Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Number of Pegs Dropped: Study A0221109 |
0.0; 0.5; 0.0; -0.5; 0.0; 0.5 | — |
| PRIMARY Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 28- Number of Pegs Dropped: Study A0221109 |
0.0; 0.0; 0.0; -0.5 | — |
| PRIMARY Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Final Visit- Number of Pegs Dropped: Study A0221109 |
0.0; 0.0; 0.0; -0.5 | — |
| PRIMARY Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Number of Pegs Placed Correctly: Study A0221109 |
10.0; 10.0; 0.0; 0.0; 10.0; 10.0 | — |
| PRIMARY Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 28- Number of Pegs Placed Correctly: Study A0221109 |
0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Final Visit- Number of Pegs Placed Correctly: Study A0221109 |
0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Number of Pegs Placed Correctly: Study A0221109 |
25.0; 25.0; 0.0; 0.0; 25.0; 25.0 | — |
| PRIMARY Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 28- Number of Pegs Placed Correctly: Study A0221109 |
0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Final Visit- Number of Pegs Placed Correctly: Study A0221109 |
0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Change From Baseline in Vital Sign (Blood Pressure) at Week 12: Study A0221109 |
6.0; 2.1; 5.0; 10.5; -0.9; 6.3 | — |
| PRIMARY Change From Baseline in Vital Sign (Blood Pressure) at Week 28: Study A0221109 |
8.5; 5.7; 9.7; 12.0; 5.3; 10.7 | — |
| PRIMARY Change From Baseline in Vital Sign (Blood Pressure) at Final Visit: Study A0221109 |
8.5; 5.1; 9.7; 12.0; 4.6; 10.7 | — |
| PRIMARY Change From Baseline in Vital Sign (Pulse Rate) at Week 12: Study A0221109 |
0.0; 2.4; -8.0 | — |
| PRIMARY Change From Baseline in Vital Sign (Pulse Rate) at Week 28: Study A0221109 |
-3.5; -2.7; -3.7 | — |
| PRIMARY Change From Baseline in Vital Sign (Pulse Rate) at Final Visit: Study A0221109 |
-3.5; -1.4; -3.7 | — |
| PRIMARY Number of Participants With Adverse Event Urinary Tract Infections (UTI): Merged Data of Studies A0221047 and A0221109 |
0; 1; 0; 1; 0; 1 | — |
| PRIMARY Number of Participants With Clinical Laboratory Abnormalities |
2; 6; 2 | — |
| PRIMARY Change From Baseline in Post-Void Residual (PVR) Volume at Week 12: Study A0221109 |
— | — |
| PRIMARY Change From Baseline in Post-Void Residual (PVR) Volume at Week 28: Study A0221109 |
— | — |
| PRIMARY Change From Baseline in Post-Void Residual (PVR) Volume at Final Visit: Study A0221109 |
— | — |
| SECONDARY Change From Baseline in Maximum Cystometric Bladder Capacity at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109 |
181.0; 135.5; 181.0; 149.7; 102.3; 143.1 | — |
| SECONDARY Change From Baseline in Detrusor Pressure at Maximum Bladder Capacity at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109 |
29.0; 40.2; 29.0; 32.4; 58.3; 38.3 | — |
| SECONDARY Number of Participants With Presence of Involuntary Detrusor Contraction (IDC) at Baseline and Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109 |
1; 10; 1; 7; 3; 11 | — |
| SECONDARY Change From Baseline in Bladder Volume at First Involuntary Detrusor Contraction (IDC) at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109 |
175.0; 48.8; 175.0; 48.1; 50.3; 60.3 | — |
| SECONDARY Change From Baseline in Bladder Compliance at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109 |
7.00; 6.97; 7.00; 8.16; 4.20; 6.98 | — |
| SECONDARY Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109 |
4.58; 4.58; 4.58; -1.50; -1.50; -1.50 | — |
| SECONDARY Change From Baseline in Mean Number of Catheterizations Per 24 Hours at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109 |
5.33; 4.47; 5.33; 4.24; 5.00; 4.61 | — |
| SECONDARY Change From Baseline in Mean Number of Micturitions or Catheterizations Combined Per 24 Hours at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109 |
5.33; 6.30; 5.33; 6.86; 5.00; 6.14 | — |
| SECONDARY Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109 |
1.17; 3.60; 1.17; 3.48; 3.89; 3.19 | — |
| SECONDARY Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109 |
0.61; 0.75; 0.33; 0.61; -0.61; -0.75 | — |
| SECONDARY Change From Baseline in Mean Volume Voided Per Micturition at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109 |
73.42; 73.42; 73.42; 15.77; 15.77; 15.77 | — |
| SECONDARY Change From Baseline in Mean Volume Voided Per Catheterization at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109 |
198.75; 58.31; 198.75; 48.76; 80.58; 81.72 | — |
| SECONDARY Change From Baseline in Mean Volume Voided Per Micturition or Catheterization at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109 |
198.75; 65.68; 198.75; 59.29; 80.58; 87.86 | — |
Summary
The purpose of this study is to investigate the safety and tolerability of fesoterodine following once daily long-term treatment in Japanese pediatric neurogenic detrusor overactivity (NDO) subjects.
Eligibility Criteria
Inclusion Criteria
•Subjects who completed 24 week treatment and all visit procedures in the precedent Study A0221047
Exclusion Criteria
- Subjects who had major protocol violation (as determined by the Sponsor) in Study A0221047
- 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
Data sourced from ClinicalTrials.gov (NCT02501928). 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.