Ignite Creation Date:
2025-12-18 @ 8:11 AM
Ignite Modification Date:
2025-12-18 @ 8:11 AM
Study NCT ID:
NCT00269724
Status:
None
Last Update Posted:
2011-05-19 00:00:00
First Post:
2005-12-22 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Efficacy of OROS® Oxybutynin Chloride for the Treatment of Urge Urinary Incontinence
Sponsor:
None
Organization:
Study Overview
Official Title:
Open-Label Safety And Dose Conversion/Determination Study of OROS® Oxybutynin Chloride for Urge Urinary Incontinence
Status:
None
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Urinary incontinence refers to the involuntary loss of urine in sufficient amounts to be considered a social or health problem. It is under-reported and under-treated as patients are often ashamed and embarrassed to discuss their condition and clinicians may also fail to ask patients about incontinence. This is a multi-center, open-label study including dose conversion and dose determination to evaluate the safety of OROS® oxybutynin chloride at a clinically acceptable dose. There are three study periods: Run-in, Dose Conversion/Determination, and Maintenance. During the 1-week Run-in Period, baseline incontinence, urinary frequency, and health related quality-of-life data are collected. During the Dose Conversion/Determination Period, any previous urge urinary incontinence medications are discontinued and each patient is started on OROS® oxybutynin chloride. The dose is titrated to a clinically acceptable dose in 5-mg increments at 7 ± 3 day intervals to a possible maximum dose of 30 mg/day. The clinically acceptable dose is defined as either the minimum effective dose (i.e., the dose at which the patient has no incontinent episodes for the last 2 days of the dosing interval) or the dose providing the best balance between symptomatic improvement and side effects. Patients taking immediate-release oxybutynin at enrollment started dose titration on OROS® oxybutynin chloride at a dose equal to their immediate-release oxybutynin dose; all others started at 5 mg per day OROS® (oxybutynin chloride). After the clinically acceptable dose is established, the patient continues for an additional week at that dose to confirm that it is appropriate. Then the patient enters the 12-week Maintenance Period that evaluates whether the urge urinary incontinence reduction that is achieved by the beginning of maintenance has persisted. The primary outcome of the study is an evaluation of the safety of OROS® oxybutynin chloride. Safety assessments include the incidence of adverse events, physical examination and medical history, clinical laboratory tests, urinalysis, electrocardiograms (ECGs), vital signs, and the Physician's Anticholinergic Effects Assessment (P-ACEA), an assessment completed by the physician if severe or intolerable anticholinergic effects occur.
OROS® oxybutynin chloride (5 mg and 10 mg systems): One to five systems taken orally per day (5 mg per day to a maximum of 30 mg per day) as a single morning dose. The duration of the Maintenance Period of the study is 12 weeks.
OROS® oxybutynin chloride (5 mg and 10 mg systems): One to five systems taken orally per day (5 mg per day to a maximum of 30 mg per day) as a single morning dose. The duration of the Maintenance Period of the study is 12 weeks.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: