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Safety and Efficacy Evaluation of Oxybutynin Topical Gel In Children With Neurogenic Bladder

This study has suspended participant recruitment.
(Slow enrollment despite considerable efforts led to agreement with agency to modify study to an open label study)
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01192568
First received: August 30, 2010
Last updated: December 13, 2016
Last verified: December 2016
  Purpose
This study will evaluate the safety and efficacy of Oxybutynin Chloride 10% Topical Gel in children 3 to less than 17 years old, who have overactive bladder due to a neurogenic condition. Children will be treated with 0.75 g of gel/day for two weeks. Patients will then return to the clinic for a potential dose titration. At this time their dose may be adjusted up to 1g/day, down to 0.5g/day, or remain the same at 0.75g of gel/day depending on the individual response and tolerability. The total treatment time is 14 weeks and total time on the study is 16 weeks.

Condition Intervention Phase
Overactive Detrusor Neurogenic Bladder Drug: Oxybutynin Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Two-part, Multicenter, Dose-titration Study Evaluating Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of Oxybutynin Chloride 10% Gel for Treatment of Detrusor Overactivity Associated Neurological Condition in Pediatric Patients

Resource links provided by NLM:


Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:
  • Percentage of catheterizations without a leaking accident. [ Time Frame: baseline (week 0) up to week 6 ]
    The primary efficacy endpoint is the change from baseline to Week 6 of treatment or the last observation carried forward in percentage of catheterizations without a leaking accident as recorded in a 2-day urinary diary.


Secondary Outcome Measures:
  • Average volume of urine collected per catheterization [ Time Frame: baseline (week 0) up to week 6 ]
  • Average volume of urine collected at first (morning awakening) catheterization [ Time Frame: baseline (week 0) up to week 6 ]
  • Average number of catheterizations per day [ Time Frame: baseline (week 0) up to week 6 ]

Estimated Enrollment: 58
Study Start Date: May 2011
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oxybutynin Chloride Drug: Oxybutynin
10% Oxybutynin Chloride Topical Gel, 0.5 g, 0.75 g, and 1 g/day, administered transdermally.
Other Name: Gelnique

Detailed Description:
This study will use a two-part, multicenter, dose-titration study in pediatric patients with a detrusor overactivity associated with a neurological condition
  Eligibility

Ages Eligible for Study:   3 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 3 years to < 17 years
  • Neurogenic bladder
  • Neurological condition
  • CIC

Exclusion Criteria:

  • Have anatomical bladder abnormalities
  • Sensitivity to anticholinergics
  • Bladder augmentation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01192568

Locations
United States, California
Investigational Site
Loma Linda, California, United States
Investigational Site
Long Beach, California, United States
United States, Michigan
Investigational Site
Detroit, Michigan, United States
United States, North Carolina
Investigational Site
Charlotte, North Carolina, United States
United States, Ohio
Investigational Site
Akron, Ohio, United States
United States, Virginia
Investigational Site
Norfolk, Virginia, United States
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
Study Director: Gina Giannantoni-Ibelli Allergan Sales, LLC
  More Information

Publications:
Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01192568     History of Changes
Other Study ID Numbers: OG09002
Study First Received: August 30, 2010
Last Updated: December 13, 2016

Additional relevant MeSH terms:
Urinary Bladder, Neurogenic
Urinary Bladder, Overactive
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms
Lower Urinary Tract Symptoms
Urological Manifestations
Oxybutynin
Mandelic Acids
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents

ClinicalTrials.gov processed this record on June 23, 2017