Open-label Long-term Extension Study of Fesoterodine in Japanese Subjects With Neurogenic Detrusor Overactivity.

NCT02501928

Last updated date
Study Location
Aichi Children's Health and Medical Center
Obu, Aichi, 474-8710, Japan
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neurogenic Urinary Bladder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-17 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

•Subjects who completed 24 week treatment and all visit procedures in the precedent Study A0221047

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Neurogenic Urinary BladderOpen-label Long-term Extension Study of Fesoterodine in Japanese Subjects With Neurogenic Detrusor Overactivity.
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Advanced Information
Descriptive Information
Brief Title  ICMJE Open-label Long-term Extension Study of Fesoterodine in Japanese Subjects With Neurogenic Detrusor Overactivity.
Official Title  ICMJE LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY OF FESOTERODINE IN JAPANESE PEDIATRIC SUBJECTS WITH SYMPTOMS OF DETRUSOR OVERACTIVITY ASSOCIATED WITH A NEUROLOGICAL CONDITION (NEUROGENIC DETRUSOR OVERACTIVITY) WHO HAVE COMPLETED 24 WEEKS TREATMENT IN STUDY A0221047
Brief 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.
Detailed Description

This is a Phase 3, multi-center, open-label long-term extension study in Japanese NDO subjects who participated and completed in the precedent Study A0221047 which is a 24 weeks, randomized, open label study, to investigate the safety and tolerability of fesoterodine.

This study consists of a 28-week open-label treatment period followed by a 4-week follow-up. In addition, subjects in the oxybutynin arm of the precedent Study A0221047 will continue the fesoterodine treatment until Week 40 visit in this study, in order to obtain fesoterodine 1 year treatment data.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Urinary Bladder, Neurogenic
Intervention  ICMJE
  • Drug: Fesoterodine PR 4 mg
    Fesoterodine 4 mg tablet once daily for 28 or 40 weeks
  • Drug: Fesoterodine PR 8 mg
    Fesoterodine PR 8 mg tablet once daily for 28 or 40 weeks
  • Drug: Fesoterodine BIC 2 mg
    Fesoterodine BIC 2 mg tablet once daily for 28 weeks
  • Drug: Fesoterodine BIC 4 mg
    Fesoterodine BIC 4 mg tablet once daily for 28 weeks
Study Arms  ICMJE
  • Experimental: Fesoterodine PR 4 mg
    Fesoterodine PR 4 mg for 28 or 40 weeks in open-label treatment period
    Intervention: Drug: Fesoterodine PR 4 mg
  • Experimental: Fesoterodine PR 8 mg
    Fesoterodine PR 8 mg for 28 or 40 weeks in open-label treatment period
    Intervention: Drug: Fesoterodine PR 8 mg
  • Experimental: Fesoterodine BIC 2 mg
    Fesoterodine BIC 2 mg for 28 weeks in open-label treatment period
    Intervention: Drug: Fesoterodine BIC 2 mg
  • Experimental: Fesoterodine BIC 4 mg
    Fesoterodine BIC 4 mg for 28 weeks in open-label treatment period
    Intervention: Drug: Fesoterodine BIC 4 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 20, 2020)
12
Original Estimated Enrollment  ICMJE
 (submitted: July 15, 2015)
9
Actual Study Completion Date  ICMJE April 1, 2020
Actual Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02501928
Other Study ID Numbers  ICMJE A0221109
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP