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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02501928
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : May 22, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Urinary Bladder, Neurogenic Drug: Fesoterodine PR 4 mg Drug: Fesoterodine PR 8 mg Drug: Fesoterodine BIC 2 mg Drug: Fesoterodine BIC 4 mg Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 5, 2015
Actual Primary Completion Date : March 4, 2020
Actual Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fesoterodine PR 4 mg
Fesoterodine PR 4 mg for 28 or 40 weeks in open-label treatment period
Drug: Fesoterodine PR 4 mg
Fesoterodine 4 mg tablet once daily for 28 or 40 weeks

Experimental: Fesoterodine PR 8 mg
Fesoterodine PR 8 mg for 28 or 40 weeks in open-label treatment period
Drug: Fesoterodine PR 8 mg
Fesoterodine PR 8 mg tablet once daily for 28 or 40 weeks

Experimental: Fesoterodine BIC 2 mg
Fesoterodine BIC 2 mg for 28 weeks in open-label treatment period
Drug: Fesoterodine BIC 2 mg
Fesoterodine BIC 2 mg tablet once daily for 28 weeks

Experimental: Fesoterodine BIC 4 mg
Fesoterodine BIC 4 mg for 28 weeks in open-label treatment period
Drug: Fesoterodine BIC 4 mg
Fesoterodine BIC 4 mg tablet once daily for 28 weeks




Primary Outcome Measures :
  1. 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.

  2. Change in visual acuity from baseline [ Time Frame: 28 or 40 weeks ]
  3. 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

  4. Change in cognitive function from baseline by the Child Behavior Checklist and Grooved Pegboard Test [ Time Frame: 28 or 40 weeks ]
  5. Change in blood pressure from baseline [ Time Frame: 28 or 40 weeks ]
  6. Change in temperature from baseline [ Time Frame: 28 or 40 weeks ]
  7. Change in pulse rate from baseline [ Time Frame: 28 or 40 weeks ]
  8. Incidence of urinary tract infection [ Time Frame: 28 or 40 weeks ]
  9. Change in clinical laboratory (hematology) from baseline [ Time Frame: 28 or 40 weeks ]
  10. Change in clinical laboratory (chemistry) from baseline [ Time Frame: 28 or 40 weeks ]
  11. Change in clinical laboratory (urinalysis) from baseline [ Time Frame: 28 or 40 weeks ]
  12. Change in post-void residual volume from baseline [ Time Frame: 28 or 40 weeks ]

Secondary Outcome Measures :
  1. Change in maximum cystometric bladder capacity (Urodynamics assessment) from baseline [ Time Frame: 28 or 40 weeks ]
  2. Change in detrusor pressure at maximum bladder capacity (Urodynamics assessment) [ Time Frame: 28 or 40 weeks ]
  3. Presence of involuntary detrusor contractions (Urodynamics assessment) [ Time Frame: 28 or 40 weeks ]
  4. Change in bladder volume at first involuntary detrusor contraction (Urodynamics assessment) from baseline [ Time Frame: 28 or 40 weeks ]
  5. Change in bladder compliance (Urodynamics assessment) from baseline [ Time Frame: 28 or 40 weeks ]
  6. Change in mean number of micturitions and/or catheterizations/24 hours from baseline [ Time Frame: 28 or 40 weeks ]
  7. Change in mean number of incontinence episodes/24 hours from baseline [ Time Frame: 28 or 40 weeks ]
  8. Change in mean urgency episodes/24 hours from baseline, if applicable [ Time Frame: 28 or 40 weeks ]
  9. Change in mean volume voided per micturition or mean volume per catheterization from baseline [ Time Frame: 28 or 40 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501928


Locations
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Japan
Aichi Children's Health and Medical Center
Obu, Aichi, Japan, 474-8710
Chiba Children's Hospital
Midori-ku Chiba-shi, Chiba, Japan, 266 0007
Fukuoka Children's Hospital
Fukuoka-shi, Fukuoka, Japan, 813-0017
Kanagawa Children's Medical Center
Yokohama, Kanagawa, Japan, 232-8555
Osaka Women's and Children's Hospital
Izumi-shi, Osaka, Japan, 594-1101
Shizuoka Children's Hospital
Aoi-ku Shizuoka-shi, Shizuoka, Japan, 420 8660
Dokkyo Medical University Hospital
Shimotsuga-gun, Tochigi, Japan, 321-0293
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02501928    
Other Study ID Numbers: A0221109
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
neurogenic detrusor overactivity
fesoterodine
Japan
Additional relevant MeSH terms:
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Urinary Bladder, Neurogenic
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Neurologic Manifestations
Nervous System Diseases
Fesoterodine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents