A Study Evaluating Oxybutynin in Patients With Neurogenic Overactive Bladder Associated With a Neurological Condition
Information source: Watson Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Detrusor Hyperreflexia
Intervention: Oxybutynin transdermal system (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Watson Pharmaceuticals Official(s) and/or principal investigator(s): Gary Hoel, RPh, PhD, Study Director, Affiliation: Watson Laboratories, Inc.
Summary
This study will evaluate the efficacy and safety of an anticholinergic drug treatment
administered by transdermal patch to treat overactive bladder in adults who have spinal cord
injury.
Clinical Details
Official title: A Multi-center, Open-label, Dose-titration Pilot Study Evaluating the Efficacy and Safety of Oxybutynin Transdermal Systems in Patients With Neurogenic Bladder Resulting From Spinal Cord Injury
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Average Number of Catheterizations Without Leaking Per Day
Secondary outcome: Patch AdhesionUrodynamic Measurements Urinary Leakage and Catheterization Data
Detailed description:
The Dose Titration Period began with a 3. 9 mg/day or 7. 8 mg/day as a starting dose after the
completion of a 3-day diary for baseline evaluations, including urodynamic testing. The
clean intermittent catheterization (CIC) frequency remained constant throughout the Dose
Titration Period. The dose was adjusted every two weeks during the Dose Titration Period by
increasing one dose level, at the investigator's discretion, based on the patient's
symptoms. If a patient achieved complete continence and reported tolerable or absence of
side effects, the patient was continued at that dose for the duration of the 8-week
Titration Period. If a patient reported unacceptable side effects, the dose was reduced by
one level. This reduced dose was considered the maximum tolerable dose for the patient and
the patient continued at that dose for the duration of the 8-week Titration Period. The dose
levels evaluated were 3. 9 mg/day, 7. 8 mg/day, 9. 1 mg/day, and 11. 7 mg/day. Of the 22
subjects in the modified intent-to-treat population evaluated for efficacy, 0 were in the
3. 9 mg/day dose group, 3 were in the 7. 8 mg/day dose group, 8 were in the 9. 1 mg/day dose
group, and 11 were in the 11. 7 mg/day dose group.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- At least 18 years of age at day of consent;
- Is a male, or is a non-pregnant non-lactating female who is either of
non-child-bearing potential, or is using adequate means of birth control;
- Has a h/o of urinary incontinence from neurogenic bladder of spinal cord injury
etiology;
- Has impairment based on the American Spinal Injury Association (ASIA);
- Use clean intermittent catheterization;
- Has urinary incontinence between scheduled catheterization;
- Capable of understanding and complying with the protocol.
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;
- History of major lower urinary tract surgery, procedures;
- Has an active skin disorder, affecting TDS application site areas;
- Hypersensitivity to the investigational drug;
- Has participated in any study involving administration of an investigational compound
within 30 days before this study.
Locations and Contacts
Atlanta, Georgia, United States
Bronx, New York, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Dallas, Texas, United States
Houston, Texas, United States
Additional Information
Starting date: December 2004
Last updated: April 7, 2010
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