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

NCT01557244

Last updated date
Study Location
Hyogo prefectural Kobe Children's Hospital
Kobe, Hyôgo, 650-0047, 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 aged 6 to 17 years old

- Subjects with stable neurological disease and neurogenic detrusor overactivity

- Subjects using clean intermittent catheterization may participate

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


- 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.

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Neurogenic Urinary BladderA Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition
NCT01557244
  1. Kobe, Hyôgo
  2. Orange, California
  3. Orange, California
  4. Atlanta, Georgia
  5. Atlanta, Georgia
  6. Atlanta, Georgia
  7. Maywood, Illinois
  8. Maywood, Illinois
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  30. Mönchengladbach, Nordrhein-westfalen
  31. Larissa,
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  34. Ludhiana, Punjab
  35. Lucknow, Uttar Pradesh
  36. Cagliari,
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  40. Vicenza,
  41. Obu, Aichi
  42. Chiba-shi, Chiba, Japan
  43. Fukuoka-shi, Fukuoka
  44. Sapporo, Hokkaido
  45. Yokohama, Kanagawa
  46. Matsumoto, Nagano
  47. Izumi-shi, Osaka
  48. Koshigaya, Saitama
  49. Shizuoka-shi, Shizuoka
  50. Shimotsuga-gun, Tochigi
  51. Shimotsuke, Tochigi
  52. Bunkyo-ku, Tokyo
  53. Yangsan-si, Gyeongsangnam-do, Korea
  54. Seoul, Korea
  55. Seoul,
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  60. Vilnius,
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  85. Istanbul,
  86. Leeds,
  87. Leicester,
  88. Newcastle Upon Tyne,
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Advanced Information
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 Completed
Actual Enrollment  ICMJE
 (submitted: March 10, 2020)
181
Original Estimated Enrollment  ICMJE
 (submitted: March 15, 2012)
132
Actual Study Completion Date  ICMJE February 13, 2020
Actual Primary Completion Date November 7, 2019   (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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Estonia,   Finland,   France,   Germany,   Greece,   India,   Italy,   Japan,   Korea, Republic of,   Lithuania,   Malaysia,   Philippines,   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/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 October 2020

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