A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition

• ClinicalTrials.gov Identifier: NCT01557244
• Recruitment Status: Completed
• First Posted: March 19, 2012
• Results First Posted: February 2, 2021
• Last Update Posted: February 2, 2021
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Urinary Bladder, Neurogenic	Drug: Fesoterodine PR 4 mg; Drug: Fesoterodine PR 8 mg; Drug: Oxybutynin; Drug: Fesoterodine PR; Drug: Fesoterodine BIC 2 mg; Drug: Fesoterodine BIC 4 mg	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 181 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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)
• Actual Study Start Date: July 2, 2012
• Actual Primary Completion Date: November 7, 2019
• Actual Study Completion Date: February 13, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Fesoterodine PR 4 mg; Fesoterodine PR 4 mg for 12 weeks in active comparator period, followed by 12 weeks in safety extension period	Drug: Fesoterodine PR 4 mg; Fesoterodine 4 mg tablet once daily for 24 weeks
Experimental: Fesoterodine PR 8 mg; Fesoterodine 8 mg for first week followed by 11 weeks at 8 mg in active control period, followed by 12 weeks in safety extension period.	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.
Active Comparator: Oxybutynin; Oxybutynin	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.; Other Name: Safety extension phase
Experimental: Fesoterodine BIC 2 mg; Fesoterodine BIC 2 mg for 12 weeks in efficicay period, followed by 12 weeks in safety extension period.	Drug: Fesoterodine BIC 2 mg; Fesoterodine BIC 2 mg tablet once daily for 24 weeks.
Experimental: Fesoterodine BIC 4 mg; Fesoterodine BIC 4 mg for first week followed by 11 weeks at 8 mg in the efficacy period, followed by 12 weeks in safety extension period.	Drug: Fesoterodine BIC 4 mg; Fesoterodine BIC 4 mg tablet once daily for 24 weeks, with the first week being 2 mg.

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Maximum Cystometric Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase [ Time Frame: Baseline, Week 12 ]
   Maximum cystometric bladder capacity (in milliliter) was defined as maximal tolerable cystometric capacity, until voiding or leaking begins or at a pressure of >=40 centimeter (cm) water (H2O).

Secondary Outcome Measures :

1. Change From Baseline in Detrusor Pressure at Maximum Bladder Capacity at Week 12: Active Comparator Phase/Efficacy Phase [ Time Frame: Baseline, Week 12 ]
   Detrusor pressure (in cm H2O) at maximum urinary bladder capacity was measured using urodynamic testing.
2. Number of Participants With Shift From Baseline at Week 12 in Involuntary Detrusor Contractions (IDC): Active Comparator Phase/Efficacy Phase [ Time Frame: Baseline, Week 12 ]
   In this outcome measure, shift data have been reported using 4 categories: (1) number of participants who did not have IDC at Baseline and at Week 12, (2) number of participants who did not have IDC at Baseline but had IDC at Week 12, (3) number of participants who had IDC at Baseline but no IDC at Week 12, and (4) number of participants who had IDC at Baseline and at Week 12.
3. Change From Baseline in Bladder Volume at First Involuntary Detrusor Contraction (IDC) at Week 12: Active Comparator Phase/Efficacy Phase [ Time Frame: Baseline, Week 12 ]
   Bladder volume (in milliliter) at first IDC was measured using urodynamic testing.
4. Change From Baseline in Bladder Compliance at Week 12: Active Comparator Phase/Efficacy Phase [ Time Frame: Baseline, Week 12 ]
   Bladder compliance was defined as change in bladder volume in milliliter (mL) divided by change in bladder pressure in cm H2O (during the same time when change in bladder volume was estimated).
5. Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase [ Time Frame: Baseline, Week 12 ]
   The mean number of micturitions per 24 hours were calculated as the total number of micturitions divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed on, even if it was not a full 24 hour period. This outcome measure was only calculated for participants with >0 micturitions at Baseline.
6. Change From Baseline in Mean Number of Catheterizations Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase [ Time Frame: Baseline, Week 12 ]
   The mean number of catheterizations per 24 hours were calculated as the total number of catheterizations divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed on; even if it was not a full 24 hours period. This outcome measure was only calculated for participants with >0 catheterizations at Baseline.
7. Change From Baseline in Mean Number of Micturitions or Catheterizations Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase [ Time Frame: Baseline, Week 12 ]
   The mean number of micturitions or catheterizations combined per 24 hours were calculated as the total number of micturitions and catheterizations combined divided by the total number of diary days collected at the assessment point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed; even if it was not a full 24 hour (hrs) period. This outcome was evaluated in those participants who had micturitions or catheterizations >0 at Baseline.
8. Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase [ Time Frame: Baseline, Week 12 ]
   The mean number of incontinence episodes per 24 hours were calculated as the total number of incontinence episodes divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed; even if it was not a full 24 hours period. This outcome measure was only calculated for participants with >0 incontinence episodes at Baseline.
9. Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12: Active Comparator Phase/Efficacy Phase [ Time Frame: Baseline, Week 12 ]
   The mean number of urgency episodes per 24 hours were calculated as the total number of urgency episodes divided by the total number of diary days collected at the assessment time point. Number of diary days collected at the assessment time point = number of calendar days when the diary was completed; even if it was not a full 24 hours period. Urgency episodes were defined as urgency marked as 'yes' in the diary. This outcome measure was only calculated for participants with >0 urgency episodes at Baseline.
10. Change From Baseline in Mean Volume Voided Per Micturition at Week 12: Active Comparator Phase/Efficacy Phase [ Time Frame: Baseline, Week 12 ]
    The mean voided volume per micturition was calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0.
11. Change From Baseline in Mean Volume Voided Per Catheterization at Week 12: Active Comparator Phase/Efficacy Phase [ Time Frame: Baseline, Week 12 ]
    The mean volume per catheterization was calculated as sum of voided volume divided by the total number of catheterization, with a recorded voided volume greater than 0.
12. Change From Baseline in Mean Volume Voided Per Micturition or Catheterization at Week 12: Active Comparator Phase/Efficacy Phase [ Time Frame: Baseline, Week 12 ]
    The mean voided volume per micturition or catheterization was calculated as sum of voided volume divided by the total number of micturition or catheterization episodes with a recorded voided volume greater than 0. This outcome was evaluated in those participants who had micturitions or catheterizations >0 at Baseline.
13. Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Active Comparator Phase/Efficacy Phase [ Time Frame: Baseline up to Week 12 ]
    An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both all serious and non-serious adverse events.
14. Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Safety Extension Phase [ Time Frame: Week 12 up to Week 26 (including 2 weeks of follow up after last dose) ]
    An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both all serious and non-serious adverse events.
15. Change From Baseline in Visual Acuity at Week 12: Active Comparator Phase/Efficacy Phase [ Time Frame: Baseline, Week 12 ]
    Visual acuity (VA) was assessed using the Snellen method, where logarithm of minimum angle of resolution (logMAR) units were derived from the Snellen ratios. Participants had to read letters from the chart at a distance of 20 feet/6 meter or 4 meter. VA/Snellen ratio = distance between the chart and participant, divided by the distance at which participant was able to see or read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this outcome measure data have been reported for right and left eye separately.
16. Change From Baseline in Visual Acuity at Week 24: Safety Extension Phase [ Time Frame: Baseline, Week 24 ]
    VA was assessed using the Snellen method, where logMAR units were derived from the Snellen ratios. Participants had to read letters from the chart at a distance of 20 feet/6 meter or 4 meter. VA/Snellen ratio = distance between the chart and participant, divided by the distance at which participant was able to see or read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this outcome measure data have been reported for right and left eye separately.
17. Change From Baseline in Visual Accommodation at Week 12: Active Comparator Phase/Efficacy Phase [ Time Frame: Baseline, Week 12 ]
    The visual accommodation was the distance for each eye at which vision became blurred and was calculated as the mean of triplicate measurements. The participants focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the participant until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this outcome measure data have been reported for right and left eye separately.
18. Change From Baseline in Visual Accommodation at Week 24: Safety Extension Phase [ Time Frame: Baseline, Week 24 ]
    The visual accommodation is the distance for each eye at which vision became blurred and was calculated as the mean of triplicate measurements. The participants focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the participant until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this outcome measure data have been reported for right and left eye separately.
19. Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Active Comparator Phase/Efficacy Phase [ Time Frame: Baseline, Week 12 ]
    CBCL: 120 items questionnaire answered by parent/caregiver of child to assess a child's behavioral, emotional problems. Scale for each item: 0= not true, 1= somewhat/sometimes true, 2= very true/often true. Out of 120 items, 103 were categorized into 8 domains; aggressive behavior, anxious/depressed, attention problems, rule-breaking behavior, social problems, somatic complaints, thought problems, withdrawn. Summary scores: Internalizing problems=anxious/depressed + withdrawn + somatic complaints; Externalizing problems=rule-breaking + aggressive behavior. Total problems=8 domains + other 17 items. Raw scores for each domain, summary and total problems=sum of scores of related items. Using Assessment Data Manager (ADM) tool raw scores transformed/derived into standard T-scores, range: each domain=50 to 100, internalizing problems=34 to 100, externalizing problems=33 to 100, total problems=24 to 100. Lower T-score for each 8 domains, 2 summary and total problems scores=better outcomes.
20. Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 24: Safety Extension Phase [ Time Frame: Baseline, Week 24 ]
    CBCL: 120 items questionnaire answered by parent/caregiver of child to assess a child's behavioral, emotional problems. Scale for each item: 0= not true, 1= somewhat/sometimes true, 2= very true/often true. Out of 120 items, 103 were categorized into 8 domains; aggressive behavior, anxious/depressed, attention problems, rule-breaking behavior, social problems, somatic complaints, thought problems, withdrawn. Summary scores: Internalizing problems=anxious/depressed + withdrawn + somatic complaints; Externalizing problems=rule-breaking + aggressive behavior. Total problems=8 domains + other 17 items. Raw scores for each domain, summary and total problems=sum of scores of related items. Using Assessment Data Manager (ADM) tool raw scores transformed/derived into standard T-scores, range: each domain=50 to 100, internalizing problems=34 to 100, externalizing problems=33 to 100, total problems=24 to 100. Lower T-score for each 8 domains, 2 summary and total problems scores=better outcomes.
21. Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 12: Active Comparator Phase/Efficacy Phase [ Time Frame: Baseline, Week 12 ]
    CBCL: It consisted of 120 items on behavior and emotional problems. Parent/caregiver of child answered 120 items, each on scale: 0= not true, 1= somewhat/sometimes true, 2= very/often true. 103 items were classified in 8 domains: aggressive behavior: total score range (TSR)= 0 to 36, anxious/depressed: TSR= 0 to 26, attention problems: TSR= 0 to 20, rule-breaking behavior: TSR= 0 to 34, social problems: TSR= 0 to 22, somatic complaints: TSR= 0 to 22, thought problems: TSR= 0 to 30, withdrawn (TSR)= 0 to 16. Rule-breaking and aggressive behavior summarized to externalizing problems with a TSR= 0 to 70. Anxious/depressed, withdrawn, somatic complaints summarized to internalizing problems with a TSR= 0 to 64. All 103 items of 8 domains and other 17 remaining items were combined to give total problems TSR = 0 to 240. TSR for each domain, summary and total problems was sum of scores of related items respectively. Lower scores for each domain, summary and total problems= better outcomes.
22. Change From Baseline in Child Behavior Checklist Total Score (Raw Score) at Week 24: Safety Extension Phase [ Time Frame: Baseline, Week 24 ]
    CBCL: It consisted of 120 items on behavior and emotional problems. Parent/caregiver of child answered 120 items, each on scale: 0= not true, 1= somewhat/sometimes true, 2= very/often true. 103 items were classified in 8 domains: aggressive behavior: total score range (TSR)= 0 to 36, anxious/depressed: TSR= 0 to 26, attention problems: TSR= 0 to 20, rule-breaking behavior: TSR= 0 to 34, social problems: TSR= 0 to 22, somatic complaints: TSR= 0 to 22, thought problems: TSR= 0 to 30, withdrawn (TSR)= 0 to 16. Rule-breaking and aggressive behavior summarized to externalizing problems with a TSR= 0 to 70. Anxious/depressed, withdrawn, somatic complaints summarized to internalizing problems with a TSR= 0 to 64. All 103 items of 8 domains and other 17 remaining items were combined to give total problems TSR = 0 to 240. TSR for each domain, summary and total problems was sum of scores of related items respectively. Lower scores for each domain, summary and total problems= better outcomes.
23. Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase [ Time Frame: Baseline, Week 12 ]
    The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability.
24. Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase [ Time Frame: Baseline, Week 24 ]
    The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability.
25. Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase [ Time Frame: Baseline, Week 12 ]
    The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability.
26. Change From Baseline in Time to Completion Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase [ Time Frame: Baseline, Week 24 ]
    The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. In this outcome measure participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability.
27. Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase [ Time Frame: Baseline, Week 12 ]
    The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.
28. Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase [ Time Frame: Baseline, Week 24 ]
    The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.
29. Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 12: Active Comparator Phase/Efficacy Phase [ Time Frame: Baseline, Week 12 ]
    The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.
30. Change From Baseline in Number of Pegs Dropped Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase [ Time Frame: Baseline, Week 24 ]
    The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs dropped while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.
31. 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 [ Time Frame: Baseline, Week 12 ]
    The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.
32. Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 10 Pegs Group at Week 24: Safety Extension Phase [ Time Frame: Baseline, Week 24 ]
    The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.
33. 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 [ Time Frame: Baseline, Week 12 ]
    The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.
34. Change From Baseline in Number of Pegs Placed Correctly Assessment of Grooved Pegboard Test, 25 Pegs Group at Week 24: Safety Extension Phase [ Time Frame: Baseline, Week 24 ]
    The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consisted of a small board of 25 holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). In this outcome measure number of pegs placed correctly while putting in the holes were measured. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand.
35. Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 12: Active Comparator/Efficacy Phase [ Time Frame: Baseline up to Week 12 ]
    Pre-defined criteria for vital signs: 1) a) systolic blood pressure (SBP) of <90 millimeter of mercury (mmHg), b) change >=30 mmHg increase, c) change >=30 mmHg decrease; 2) a) diastolic blood pressure (DBP) of <50 mmHg, b) change >=20 mmHg increase, c) change >=20 mmHg decrease; 3) a) pulse rate value of <40 beats per minute (bpm), b) pulse rate value >120 bpm.
36. Number of Participants Meeting Pre-defined Criteria for Vital Signs Values From Baseline Through Week 24: Safety Extension Phase [ Time Frame: Baseline up to Week 24 ]
    Pre-defined criteria for vital signs: 1) a) systolic blood pressure (SBP) of <90 millimeter of mercury (mmHg), b) change >=30 mmHg increase, c) change >=30 mmHg decrease; 2) a) diastolic blood pressure (DBP) of <50 mmHg, b) change >=20 mmHg increase, c) change >=20 mmHg decrease; 3) a) pulse rate value of <40 beats per minute (bpm), b) pulse rate value >120 bpm.
37. Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Active Comparator/Efficacy Phase [ Time Frame: Week 1 up to Week 12 ]
    Clinically significant UTI, counted as an adverse event was defined as: positive urine culture with a uropathogen (defined as >=10^5 colony forming unit per milliliter [CFU/mL]) and the presence of symptoms, or pyuria (defined as >50 white blood cells [WBC] per high-pass filter [hpf]) and the presence of symptoms, or positive urine culture with a uropathogen (defined as >=10^5 CFU/mL) with or without symptoms in a participant with a documented history of vesicoureteral reflux (VUR).
38. Number of Participants With Clinically Significant Urinary Tract Infections (UTI): Safety Extension Phase [ Time Frame: Week 12 up to Week 26 ]
    Clinically significant UTI, counted as an adverse event was defined as: positive urine culture with a uropathogen (defined as >=10^5 CFU/mL) and the presence of symptoms, or pyuria (defined as >50 WBC per hpf and the presence of symptoms, or positive urine culture with a uropathogen (defined as >=10^5 CFU/mL) with or without symptoms in a participants with a documented history of VUR.
39. Number of Participants With Clinical Laboratory Abnormalities: Active Comparator/Efficacy Phase [ Time Frame: Week 1 up to Week 12 ]
    Hematology: hemoglobin, hematocrit, erythrocytes <0.8*lower limit of normal (LLN), platelets<0.5*LLN>1.75*upper limit of normal (ULN), leukocytes <0.6*LLN>1.5*ULN, lymphocytes, neutrophils, <0.8*LLN >1.2*ULN, basophils, eosinophils, monocytes monocytes/leukocytes >1.2*ULN. Clinical chemistry: bilirubin, direct, bilirubin >1.5*ULN, aspartate aminotransferase (AT), alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase>3.0*ULN, protein, albumin, phosphate <0.8*LLN >1.2*ULN, blood urea nitrogen, creatinine >1.3*ULN, urate >1.2*ULN, sodium<0.95*LLN>1.05*ULN, potassium, chloride, calcium bicarbonate<0.9*LLN>1.1*ULN, glucose<0.6*LLN>1.5*ULN, creatine kinase >2.0*ULN. Urinalysis: specific gravity <1.003>1.030, pH <4.5>8, urine glucose, ketones, urine protein, urine hemoglobin, urine bilirubin, nitrite, >=1, urine erythrocytes, urine leukocytes >=20, epithelial cells >=6, bacteria >20.
40. Number of Participants With Clinical Laboratory Abnormalities: Safety Extension Phase [ Time Frame: Week 12 up to Week 26 ]
    Hematology: hemoglobin, hematocrit, erythrocytes <0.8*lower limit of normal (LLN), platelets<0.5*LLN>1.75*upper limit of normal (ULN), leukocytes <0.6*LLN>1.5*ULN, lymphocytes, neutrophils, <0.8*LLN >1.2*ULN, basophils, eosinophils, monocytes monocytes/leukocytes >1.2*ULN. Clinical chemistry: bilirubin, direct, bilirubin >1.5*ULN, aspartate aminotransferase (AT), alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase>3.0*ULN, protein, albumin, phosphate <0.8*LLN >1.2*ULN, blood urea nitrogen, creatinine >1.3*ULN, urate >1.2*ULN, sodium<0.95*LLN>1.05*ULN, potassium, chloride, calcium bicarbonate<0.9*LLN>1.1*ULN, glucose<0.6*LLN>1.5*ULN, creatine kinase >2.0*ULN. Urinalysis: specific gravity <1.003>1.030, pH <4.5>8, urine glucose, ketones, urine protein, urine hemoglobin, urine bilirubin, nitrite, >=1, urine erythrocytes, urine leukocytes >=20, epithelial cells >=6, bacteria >20.
41. Change From Baseline in Post-Void Residual (PVR) Volume at Weeks 4, 12: Active Comparator Phase/Efficacy Phase [ Time Frame: Baseline, Week 4, 12 ]
    Post-void residual volume measurement was measured by an ultrasound. PVR volume was only assessed for participants who did not perform clean intermittent catheterization or in any participants who had >1 UTI during the study.
42. Change From Baseline in Post-Void Residual Volume at Week 24: Safety Extension Phase [ Time Frame: Baseline, Week 24 ]
    Post-void residual volume measurement was measured by an ultrasound. PVR volume was only assessed for participants who did not perform clean intermittent catheterization or in any participants who had >1 UTI during the study.
43. Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 12: Active Comparator/Efficacy Phase [ Time Frame: Baseline up to Week 12 ]
    Physical examination included assessment of the general appearance and the skin, head, ears, eyes, nose, mouth, throat, respiratory, cardiovascular, gastrointestinal, musculoskeletal and neurological systems. Clinically relevant changes in physical findings were assessed by the investigator.
44. Number of Participants With Clinically Relevant Changes in Physical Examination Findings From Baseline to Week 24: Safety Extension Phase [ Time Frame: Baseline up to Week 24 ]
    Physical examination included assessment of the general appearance and the skin, head, ears, eyes, nose, mouth, throat, respiratory, cardiovascular, gastrointestinal, musculoskeletal and neurological systems. Clinically relevant changes in physical findings were assessed by the investigator.
45. Absorption Rate Constant (Ka) of Fesoterodine [ Time Frame: Week 4, Day 1: pre-dose (when dose administered at clinic) or if dose taken at home up to 3 hours before coming to the clinic, sampling just after arrival at clinic, 5 hours post-dose, 8-10 hours post-dose (if participants remained at clinic) ]
    Absorption rate constant is used to determine rate at which drug is entering into body. Pharmacokinetic (PK) analysis was not done separately for each dose of fesoterodine in respective cohorts and were combined for PK analysis using PK modelling approach.
46. Apparent Oral Clearance (CL/F) of Fesoterodine [ Time Frame: Week 4, Day 1: pre-dose (when dose administered at clinic) or if dose taken at home up to 3 hours before coming to the clinic, sampling just after arrival at clinic, 5 hours post-dose, 8-10 hours post-dose (if participants remained at clinic) ]
    Clearance determines the rate at which a drug is metabolized or eliminated by normal biological processes. PK analysis was not done separately for each dose of fesoterodine in respective cohorts and were combined for PK analysis using PK modelling approach.
47. Volume of Distribution (Vd) of Fesoterodine [ Time Frame: Week 4, Day 1: pre-dose (when dose administered at clinic) or if dose taken at home up to 3 hours before coming to the clinic, sampling just after arrival at clinic, 5 hours post-dose, 8-10 hours post-dose (if participants remained at clinic) ]
    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. PK analysis was not done separately for each dose of fesoterodine in respective cohorts and were combined for PK analysis using PK modelling approach.

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Arizona

Urological Associates of Southern Arizona

Tucson, Arizona, United States, 85715

United States, California

Childrens Hospital of Orange County

Orange, California, United States, 92868

CHOC Children's Urology Center

Orange, California, United States, 92868

United States, Georgia

Children's Healthcare of Atlanta

Atlanta, Georgia, United States, 30342

Georgia Urology, P.A.

Atlanta, Georgia, United States, 30342

Judson L. Hawk Jr. M.D.

Atlanta, Georgia, United States, 30342

United States, Illinois

Loyola University Medical Center

Maywood, Illinois, United States, 60153

Loyola University Outpatient Center

Maywood, Illinois, United States, 60153

United States, Iowa

The Iowa Clinic

West Des Moines, Iowa, United States, 50266

United States, North Carolina

UNC Chapel Hill Memorial Hospital

Chapel Hill, North Carolina, United States, 27514

UNC Memorial Hospital Pediatric Clinic

Chapel Hill, North Carolina, United States, 27514

United States, Ohio

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Cincinnati Children's Hospital Medical Center

Liberty Township, Ohio, United States, 45044

United States, Rhode Island

Advanced Radiology

East Providence, Rhode Island, United States, 02914

Pharma Resource

East Providence, Rhode Island, United States, 02915

University Urological Associates, Inc

Providence, Rhode Island, United States, 02904

University Urological Associates, Inc.

Providence, Rhode Island, United States, 02905

United States, Wisconsin

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Belgium

Universitair Ziekenhuis Antwerpen, Urologie

Edegem, Antwerpen, Belgium, 2650

Hôpital Universitaire des Enfants Reine Fabiola

Bruxelles, Bruxelles-capitale, Belgium, 1020

Canada, Quebec

Centre hospitalier universitaire (CHU) Sainte-Justine

Montreal, Quebec, Canada, H3T 1C5

Estonia

Tallinn Children's Hospital

Tallinn, Estonia, 13419

Finland

Tampere University Hospital

Tampere, Finland, 33520

France

Centre d'Investigation Clinique

Bron Cedex, France, 69677

Groupement Hospitalier Est - Hopital Femme Mere Enfant

Bron Cedex, France, 69677

Hôpitaux Pédiatriques de Nice CHU-Lenval

Nice, France, 06200

Germany

Kliniken Maria Hilf GmbH

Mönchengladbach, Nordrhein-westfalen, Germany, 41063

Greece

University General Hospital of Larisa/ Urology Department

Larissa, Greece, 41110

Aristotle University of Thessaloniki

Thessaloniki, Greece, 56429

India

Department of Pediatrics, Christian Medical College and Hospital

Ludhiana, Punjab, India, 141 008

Italy

I.R.C.C.S. - Ospedale "Casa Sollievo della Sofferenza" - Dipartimento Scienze Chirurgiche

San Giovanni Rotondo, Foggia, Italy, 71013

Azienda Ospedaliera G. Brotzu, Dipartimento di Medicina interna-

Cagliari, Italy, 09134

Azienda Ospedaliera Universitaria Careggi

Firenze, Italy, 50139

IRCCS Ospedale Pediatrico Bambino Gesù

Roma, Italy, 00165

ULSS 6 VICENZA - Ospedale San Bortolo di Vicenza

Vicenza, Italy, 36100

Japan

Aichi Children's Health and Medical Center

Obu, Aichi, Japan, 474 8710

Chiba Children's Hospital

Chiba-shi, Chiba, Japan, Japan, 266-0007

Fukuoka Children's Hospital

Fukuoka-shi, Fukuoka, Japan, 813-0017

Hokkaido University Hospital

Sapporo, Hokkaido, Japan, 060-8648

Hyogo prefectural Kobe Children's Hospital

Kobe, Hyogo, Japan, 650-0047

Kanagawa Children's Medical Center

Yokohama, Kanagawa, Japan, 232-8555

Shinshu University Hospital

Matsumoto, Nagano, Japan, 3908621

Osaka Medical Center and Research Institute for Maternal and Child Health

Izumi-shi, Osaka, Japan, 594-1101

Dokkyo Medical University Koshigaya Hospital

Koshigaya, Saitama, Japan, 343-8555

Shizuoka Children's Hospital

Shizuoka-shi, Shizuoka, Japan, 420 8660

Dokkyo Medical University Hospital / Urology

Shimotsuga-gun, Tochigi, Japan, 321 0293

Jichi Medical University Hospital

Shimotsuke, Tochigi, Japan, 329 0498

The University of Tokyo Hospital / Urology

Bunkyo-ku, Tokyo, Japan, 113-8655

Korea, Republic of

Pusan National University Yangsan Hospital

Yangsan-si, Gyeongsangnam-do, Korea, Republic of, 50612

Korea University Guro Hospital

Seoul, Korea, Korea, Republic of, 08308

Seoul National University Hospital

Seoul, Korea, Republic of, 03080

Severance Hospital, Yonsei University Health System

Seoul, Korea, Republic of, 03722

ASAN Medical Center

Seoul, Korea, Republic of, 05505

Samsung Medical Center

Seoul, Korea, Republic of, 06351

Lithuania

Hospital of Lithuanian University of Health Sciences Kaunas klinikos

Kaunas, Lithuania, LT-50161

Children's Hospital, Affiliate of Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania, LT-08406

Malaysia

Hospital Selayang

Batu Caves, Selangor, Malaysia, 68100

Hospital Kuala Lumpur

Kuala Lumpur, Malaysia, 50586

Philippines

Philippine Children's Medical Center

Quezon City, NCR, Philippines, 1100

Poland

Klinika Chorob Nerek i Nadcisnienia Dzieci i Mlodziezy

Gdansk, Poland, 80-952

Specjalistyczny Gabinet Lekarski Paweł Kroll

Poznan, Poland, 61-512

Russian Federation

Kazan State Medical University

Kazan, Republic OF Tatarstan, Russian Federation, 420012

Children's Republican Clinical Hospital, Department of Pediatric Surgery

Kazan, Russian Federation, 420138

Scientific Research Institute of Urology named after N.A.Lopatkin of the Hertsen Federal Medical

Moscow, Russian Federation, 105425

FGBNU Scientific center of children health

Moscow, Russian Federation, 119991

SSS - Research Clinical Institute of Pediatrics n.a. Academician Y.E.Veltishchev GBOU VPO

Moscow, Russian Federation, 125412

Slovakia

J. BREZA MEDICAL s.r.o.

Bratislava, Slovakia, 831 01

Narodny ustav detskych chorob

Bratislava, Slovakia, 833 40

South Africa

Red Cross Children's Hospital

Cape Town, Western CAPE, South Africa, 7700

Spain

Hospital Sant Joan de Deu

Esplugues de Llobregat, Barcelona, Spain, 08950

Hospital General Universitario Gregorio Marañon

Madrid, Spain, 28007

Hospital Infantil Universitario Niño Jesus

Madrid, Spain, 28009

Hospital Regional Universitario Carlos Haya

Malaga, Spain, 29011

Hospital Universitari i Politecnic La Fe

Valencia, Spain, 46026

Sweden

Akademiska barnsjukhuset

Uppsala, Sweden, 751 85

Switzerland

Universitäts-Kinderspital beider Basel

Basel, Switzerland, 4031

Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan, 704

Turkey

Necmettin Erbakan Universitesi Meram Tip Fakultesi

Konya, Konya / Turkey, Turkey, 42080

Ankara Universitesi Tip Fakultesi Ibni Sina Hastanesi

Ankara, Turkey, 06100

Hacettepe Universitesi Tip Fakultesi Uroloji Anabilim Dali

Ankara, Turkey, 06100

Istanbul Universitesi Istanbul Tip Fakultesi

Istanbul, Turkey, 34390

United Kingdom

Leicester Royal Infirmary

Leicester, United Kingdom, LE1 5WW

Alder Hey Children's Hospital

Liverpool, United Kingdom, L12 2AP

Sheffield Children's NHS Foundation Trust

Sheffield, United Kingdom, S10 2TH

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

  Study Documents (Full-Text)

Documents provided by Pfizer:

Study Protocol  [PDF] March 3, 2014

Statistical Analysis Plan  [PDF] February 25, 2020

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01557244
• Other Study ID Numbers: A0221047; 2010-022475-55 ( EudraCT Number )
• First Posted: March 19, 2012
• Results First Posted: February 2, 2021
• Last Update Posted: February 2, 2021
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:

neurogenic detrusor overactivity; neurogenic bladder; neuropathic bladder; neurologic disease; fesoterodine

Additional relevant MeSH terms:

Fesoterodine; Urinary Bladder, Neurogenic; Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Oxybutynin; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Urological Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents