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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 : Recruiting
First Posted : July 17, 2015
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE June 1, 2015
First Posted Date  ICMJE July 17, 2015
Last Update Posted Date October 15, 2018
Actual Study Start Date  ICMJE June 5, 2015
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2015)
  • Incidence of adverse events [ Time Frame: 28 or 40 weeks ]
    Adverse events, including monitoring of targeted events including, but not limited to; serious adverse event, anticholinergic effects, CNS effects and visual effects.
  • Change in visual acuity from baseline [ Time Frame: 28 or 40 weeks ]
  • Change in accommodation from baseline [ Time Frame: 28 or 40 weeks ]
    Accommodation will be assessed by the push up test to assess minimum focusing distance
  • Change in cognitive function from baseline by the Child Behavior Checklist and Grooved Pegboard Test [ Time Frame: 28 or 40 weeks ]
  • Change in blood pressure from baseline [ Time Frame: 28 or 40 weeks ]
  • Change in temperature from baseline [ Time Frame: 28 or 40 weeks ]
  • Change in pulse rate from baseline [ Time Frame: 28 or 40 weeks ]
  • Incidence of urinary tract infection [ Time Frame: 28 or 40 weeks ]
  • Change in clinical laboratory (hematology) from baseline [ Time Frame: 28 or 40 weeks ]
  • Change in clinical laboratory (chemistry) from baseline [ Time Frame: 28 or 40 weeks ]
  • Change in clinical laboratory (urinalysis) from baseline [ Time Frame: 28 or 40 weeks ]
  • Change in post-void residual volume from baseline [ Time Frame: 28 or 40 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02501928 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2015)
  • Change in maximum cystometric bladder capacity (Urodynamics assessment) from baseline [ Time Frame: 28 or 40 weeks ]
  • Change in detrusor pressure at maximum bladder capacity (Urodynamics assessment) [ Time Frame: 28 or 40 weeks ]
  • Presence of involuntary detrusor contractions (Urodynamics assessment) [ Time Frame: 28 or 40 weeks ]
  • Change in bladder volume at first involuntary detrusor contraction (Urodynamics assessment) from baseline [ Time Frame: 28 or 40 weeks ]
  • Change in bladder compliance (Urodynamics assessment) from baseline [ Time Frame: 28 or 40 weeks ]
  • Change in mean number of micturitions and/or catheterizations/24 hours from baseline [ Time Frame: 28 or 40 weeks ]
  • Change in mean number of incontinence episodes/24 hours from baseline [ Time Frame: 28 or 40 weeks ]
  • Change in mean urgency episodes/24 hours from baseline, if applicable [ Time Frame: 28 or 40 weeks ]
  • Change in mean volume voided per micturition or mean volume per catheterization from baseline [ Time Frame: 28 or 40 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 15, 2015)
9
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2020
Estimated Primary Completion Date June 30, 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: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
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 Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2018

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