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Safety and Efficacy Study of Transdermal Oxybutynin to Treat Overactive Bladder With a Neurological Condition
This study has been completed.
Sponsor:
Watson Pharmaceuticals
Information provided by (Responsible Party):
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00224016
First received: September 13, 2005
Last updated: February 7, 2012
Last verified: February 2012
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Purpose
This study will evaluate the safety and effectiveness of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in children who have a neurological condition (e.g. spina bifida) that contributes to their overactive bladder.
| Condition | Intervention | Phase |
|---|---|---|
| Detrusor Hyperreflexia | Drug: Oxybutynin | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multi-Center, Open-Label (OL), Active-Controlled, Dose-Titration Study Evaluating the Safety, Efficacy and PK of Oxybutynin Transdermal Systems in the Treatment of Detrusor Overactivity in Pediatric Patients |
Resource links provided by NLM:
Further study details as provided by Watson Pharmaceuticals:
Primary Outcome Measures:
- Average Catheterization Urine Volume [ Time Frame: 14 weeks ]Change from baseline in average volume of urine collected by catheterization
Secondary Outcome Measures:
- Catheterizations Without Leakage [ Time Frame: 14 weeks ]Percentage of catherizations without leakage
- Urine Volume After First Awakening [ Time Frame: 14 weeks ]Change from baseline in average volume of urine collected after first morning awakening
| Enrollment: | 57 |
| Study Start Date: | December 2004 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Oxybutynin Transdermal System
Oxybutynin Transdermal System 1.3 mg/day, 2.6 mg/day, or 3.9 mg/day
|
Drug: Oxybutynin
1.3, 2.6, 3.9 mg/day transdermal
Other Name: Oxytrol
|
|
Active Comparator: Oral oxybutynin
5 to 15 mg/day immediate release or extended release tablets, or syrup
|
Drug: Oxybutynin
5 to 15 mg/day immediate release or extended release tablets, or syrup
Other Name: Ditropan, Ditropan XL, Oxybutynin
|
Detailed Description:
This study will use a multicenter, randomized, open-label, active-controlled, dose-titration, parallel group design, in approximately pediatric patients with detrusor overactivity associated with a neurological condition.
Eligibility| Ages Eligible for Study: | 6 Years to 15 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Pediatric patient with a diagnosis of detrusor overactivity associated with a neurological condition;
- Use clean intermittent catheterization
- On stable dose of oral oxybutynin before participation
Exclusion Criteria:
- Have one or more treatable conditions, other than neurogenic bladder dysfunction, that may cause urinary incontinence or urgency
- Have any medical condition that precludes their participation in the study or may confound the outcome of the study
Contacts and Locations
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00224016
Show 23 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00224016
Show 23 Study Locations
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
| Study Chair: | Gary Hoel, RPh, PhD | Watson Laboratories, Inc. |
More Information
Publications:
| Responsible Party: | Watson Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00224016 History of Changes |
| Other Study ID Numbers: |
O03010 |
| Study First Received: | September 13, 2005 |
| Results First Received: | November 13, 2009 |
| Last Updated: | February 7, 2012 |
Additional relevant MeSH terms:
|
Reflex, Abnormal Neurologic Manifestations Nervous System Diseases Signs and Symptoms 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 July 21, 2017