Safety and Efficacy Study of Transdermal Oxybutynin to Treat Overactive Bladder With a Neurological Condition
![]() |
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: NCT00224016 |
Recruitment Status
:
Completed
First Posted
: September 22, 2005
Results First Posted
: December 23, 2009
Last Update Posted
: February 9, 2012
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Detrusor Hyperreflexia | Drug: Oxybutynin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 57 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | December 2004 |
Actual Primary Completion Date : | April 2007 |
Actual Study Completion Date : | September 2008 |
Arm | Intervention/treatment |
---|---|
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
|
- Average Catheterization Urine Volume [ Time Frame: 14 weeks ]Change from baseline in average volume of urine collected by catheterization
- 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

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, Learn About Clinical Studies.
Ages Eligible for Study: | 6 Years to 15 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT00224016

Study Chair: | Gary Hoel, RPh, PhD | Watson Laboratories, Inc. |
Publications of Results:
Responsible Party: | Watson Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00224016 History of Changes |
Other Study ID Numbers: |
O03010 |
First Posted: | September 22, 2005 Key Record Dates |
Results First Posted: | December 23, 2009 |
Last Update Posted: | February 9, 2012 |
Last Verified: | February 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 |