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Trial record 4 of 4 for:    Neurogenic Detrusor Overactivity | Philippines

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

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ClinicalTrials.gov Identifier: NCT01557244
Recruitment Status : Recruiting
First Posted : March 19, 2012
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE March 15, 2012
First Posted Date  ICMJE March 19, 2012
Last Update Posted Date August 22, 2019
Actual Study Start Date  ICMJE July 2, 2012
Estimated Primary Completion Date March 5, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2012)
Maximum cystometric bladder capacity [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01557244 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2012)
  • Detrusor pressure at maximum bladder capacity [ Time Frame: 12 weeks ]
  • Presence of involuntary detrusor contractions [ Time Frame: 12 weeks ]
  • Bladder volume at first involuntary detrusor contraction [ Time Frame: 12 weeks ]
  • Bladder compliance [ Time Frame: 12 weeks ]
  • Mean number of micturitions and/or catheterizations/day [ Time Frame: 12 weeks ]
  • Mean number of incontinence episodes/day [ Time Frame: 12 weeks ]
  • Mean urgency episodes/day if applicable [ Time Frame: 12 weeks ]
  • Mean volume voided per micturition or mean volume per catheterization [ Time Frame: 12 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 A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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 24 weeks
  • 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.
  • 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
  • Drug: Fesoterodine BIC 2 mg
    Fesoterodine BIC 2 mg tablet once daily for 24 weeks.
  • Drug: Fesoterodine BIC 4 mg
    Fesoterodine BIC 4 mg tablet once daily for 24 weeks, with the first week being 2 mg.
Study Arms  ICMJE
  • Experimental: Fesoterodine PR 4 mg
    Fesoterodine PR 4 mg for 12 weeks in active comparator period, followed by 12 weeks in safety extension period
    Intervention: Drug: Fesoterodine PR 4 mg
  • 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.
    Interventions:
    • Drug: Fesoterodine PR 8 mg
    • Drug: Fesoterodine PR 8 mg
  • Active Comparator: Oxybutynin
    Oxybutynin
    Interventions:
    • Drug: Oxybutynin
    • Drug: Fesoterodine PR
  • Experimental: Fesoterodine BIC 2 mg
    Fesoterodine BIC 2 mg for 12 weeks in efficicay period, followed by 12 weeks in safety extension period.
    Intervention: Drug: Fesoterodine BIC 2 mg
  • 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.
    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: August 9, 2017)
192
Original Estimated Enrollment  ICMJE
 (submitted: March 15, 2012)
132
Estimated Study Completion Date  ICMJE June 25, 2020
Estimated Primary Completion Date March 5, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 Philippines,   Belgium,   Canada,   Estonia,   Finland,   France,   Germany,   Greece,   India,   Italy,   Japan,   Korea, Republic of,   Lithuania,   Malaysia,   Poland,   Russian Federation,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries Mexico,   Netherlands,   Romania
 
Administrative Information
NCT Number  ICMJE NCT01557244
Other Study ID Numbers  ICMJE A0221047
2010-022475-55 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
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/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
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 August 2019

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