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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Aichi Children's Health and Medical Center
Obu, Aichi, 474-8710 Japan
Contact
1-800-718-1021
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

NCT02501928
Pfizer
Recruiting
Open-label Long-term Extension Study of Fesoterodine in Japanese Subjects With Neurogenic Detrusor Overactivity.

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

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.

Interventional
Phase 3
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Urinary Bladder, Neurogenic
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
9
June 2020
November 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Years to 17 Years   (Child)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Japan
 
 
NCT02501928
A0221109
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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