Open-label Long-term Extension Study of Fesoterodine in Japanese Subjects With Neurogenic Detrusor Overactivity.
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ClinicalTrials.gov Identifier: NCT02501928 |
Recruitment Status :
Completed
First Posted : July 17, 2015
Results First Posted : October 26, 2020
Last Update Posted : November 30, 2020
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Urinary Bladder, Neurogenic |
Interventions |
Drug: Fesoterodine PR 4 mg Drug: Fesoterodine PR 8 mg Drug: Fesoterodine BIC 2 mg Drug: Fesoterodine BIC 4 mg |
Enrollment | 12 |
Participant Flow
Recruitment Details | This (A0221109) was a long term extension (LTE) study only among Japanese participants who participated and completed the precedent study A0221047 (NCT01557244). Per plan, efficacy outcome measures and treatment-emergent adverse events were reported using merged data of studies A0221047 and A0221109. |
Pre-assignment Details | A0221047 had 2 cohorts. Cohort 1 had an active comparator phase and Cohort 2 had an efficacy phase followed by a safety extension phase for each cohort. Japanese participants from both cohorts, if consented continued in this LTE study and received the same treatment as in A0221047, per investigator judgment on safety and tolerance of participants. |
Arm/Group Title | Fesoterodine 4 Milligram (mg) Tablet | Fesoterodine 8 mg Tablet | Oxybutynin Then Fesoterodine 4 mg Tablet | Oxybutynin Then Fesoterodine 8 mg Tablet | Fesoterodine 2 mg Capsule | Fesoterodine 4 mg Capsule |
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Arm/Group Description | In precedent study A0221047, participants of cohort 1, with body weight greater than (>) 25 kilogram (kg), received fesoterodine 4 mg prolonged release (PR) tablet once daily for 24 weeks (12 weeks in each active comparator and safety extension phase). Only Japanese participants, who consented to continue in this LTE study, were to receive fesoterodine 4 mg PR tablet orally once daily for another 28 weeks in this LTE study. | In precedent study A0221047, participants of cohort 1, with body weight >25 kg, received fesoterodine 4 mg PR tablet once daily for 1 week and if well tolerated then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator phase and 12 weeks in safety extension phase. Only Japanese participants, who consented to continue in this LTE study, were to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study. | In precedent study A0221047, participants of cohort 1, with body weight >25 kg, received oxybutynin tablet at daily dose per pediatric labelling in active comparator phase for 12 weeks and then fesoterodine 4 mg PR tablet in safety extension phase once daily for 12 weeks. Only Japanese participants, who consented to continue in this LTE study, were to receive fesoterodine 4 mg PR tablet orally once daily for another 40 weeks in this LTE study. | In precedent study A0221047, participants of cohort 1, with body weight >25 kg, received oxybutynin tablet at daily dose per pediatric labelling in active comparator phase for 12 weeks and then fesoterodine 4 mg PR tablet once daily for 1 week and if tolerated well received 8 mg PR tablet once daily for 11 weeks in safety extension phase. Only Japanese participants, who consented to continue in this LTE study, were to receive fesoterodine 8 mg PR tablet orally once daily for another 40 weeks in this LTE study. | In precedent study A0220147, participants of cohort 2, with body weight less than or equal to (<=) 25 kg, received fesoterodine 2 mg beads-in-capsule (BIC) capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase). Only Japanese participants, who consented to continue in this LTE study, were to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study. | In precedent study A0221047, participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase. Only Japanese participants, who consented to continue in this LTE study, were to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study. |
Period Title: Overall Study | ||||||
Started | 0 [1] | 2 | 0 [1] | 0 [1] | 7 | 3 |
Completed | 0 | 2 | 0 | 0 | 6 | 3 |
Not Completed | 0 | 0 | 0 | 0 | 1 | 0 |
Reason Not Completed | ||||||
Withdrawal By Parent/Guardian | 0 | 0 | 0 | 0 | 1 | 0 |
[1]
No participant was assigned to this arm, in this LTE study.
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Baseline Characteristics
Arm/Group Title | Fesoterodine 8 mg Tablet | Fesoterodine 2 mg Capsule | Fesoterodine 4 mg Capsule | Total | |
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Arm/Group Description | Japanese participants of cohort 1, with body weight >25 kg, who received fesoterodine 4 mg PR tablet once daily for 1 week and if well tolerated then fesoterodine 8 mg PR tablet once daily for 11 weeks in active comparator phase and for 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 8 mg PR tablet orally once daily for another 28 weeks in this LTE study. | Japanese participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 24 weeks (12 weeks in each efficacy and safety extension phase) in precedent study A0221047 and who continued to receive fesoterodine 2 mg BIC capsules orally once daily for another 28 weeks in this LTE study. | Japanese participants of cohort 2, with body weight <=25 kg, received fesoterodine 2 mg BIC capsules orally once daily for 1 week and if well tolerated then fesoterodine 4 mg BIC capsules orally once daily for 11 weeks in efficacy phase and 12 weeks in safety extension phase in precedent study A0221047 and who continued to receive fesoterodine 4 mg BIC capsules orally once daily for another 28 weeks in this LTE study. | Total of all reporting groups | |
Overall Number of Baseline Participants | 2 | 7 | 3 | 12 | |
Baseline Analysis Population Description |
Baseline characteristics included only those reporting arms in which at least 1 participant was assigned. Analysis population included all enrolled participants who received at least 1 dose of study medication in this LTE study.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 2 participants | 7 participants | 3 participants | 12 participants | |
13.50 (0.71) | 7.86 (1.68) | 7.33 (0.58) | 8.67 (2.61) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 2 participants | 7 participants | 3 participants | 12 participants | |
Female |
2 100.0%
|
0 0.0%
|
1 33.3%
|
3 25.0%
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|
Male |
0 0.0%
|
7 100.0%
|
2 66.7%
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9 75.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 2 participants | 7 participants | 3 participants | 12 participants | |
Hispanic or Latino |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Not Hispanic or Latino |
2 100.0%
|
7 100.0%
|
3 100.0%
|
12 100.0%
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|
Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 2 participants | 7 participants | 3 participants | 12 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Asian |
2 100.0%
|
7 100.0%
|
3 100.0%
|
12 100.0%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Black or African American |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
White |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
More than one race |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
Prioritization of outcome measures was based on study team's discretion.
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: | Pfizer ClinicalTrials.gov Call Center |
Organization: | Pfizer Inc. |
Phone: | 1-800-718-1021 |
EMail: | ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT02501928 |
Other Study ID Numbers: |
A0221109 |
First Submitted: | June 1, 2015 |
First Posted: | July 17, 2015 |
Results First Submitted: | September 25, 2020 |
Results First Posted: | October 26, 2020 |
Last Update Posted: | November 30, 2020 |