Safety and Efficacy Study of Transdermal Oxybutynin to Treat Overactive Bladder With a Neurological Condition

This study has been completed.

Study NCT00224016 Information provided by Watson Pharmaceuticals

First Received on September 13, 2005. Last Updated on February 7, 2012 History of Changes

Results First Received: November 13, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Detrusor Hyperreflexia
Intervention:	Drug: Oxybutynin

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Oxybutynin TDS	Oxybutynin Transdermal System
Oral Oxybutynin	Oxybutynin tablets

Participant Flow for 3 periods

Period 1: Titration Period

	Oxybutynin TDS	Oral Oxybutynin
STARTED	39	16
COMPLETED	38	15
NOT COMPLETED	1	1
Withdrawal by Subject	0	1
Lost to Follow-up	1	0

Period 2: Maintenance Period

	Oxybutynin TDS	Oral Oxybutynin
STARTED	38	15
COMPLETED	36	14
NOT COMPLETED	2	1
Withdrawal by Subject	2	0
Lost to Follow-up	0	1

Period 3: Follow-Up Period

	Oxybutynin TDS	Oral Oxybutynin
STARTED	35	0 ^[1]
COMPLETED	35	0
NOT COMPLETED	0	0

[1]	This group of subjects did not proceed to follow-up period.

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Oxybutynin TDS	Oxybutynin Transdermal System
Oral Oxybutynin	Oxybutynin tablets

Baseline Measures

	Oxybutynin TDS	Oral Oxybutynin	Total
Number of Participants [units: participants]	39	16	55
Age [units: participants]
<=18 years	39	16	55
Between 18 and 65 years	0	0	0
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	10.2 ± 2.64	11.8 ± 2.82	10.6 ± 2.76
Gender [units: participants]
Female	17	11	28
Male	22	5	27
Region of Enrollment [units: participants]
United States	39	16	55

Outcome Measures

Show All Outcome Measures

1. Primary:

Average Catheterization Urine Volume [ Time Frame: 14 weeks ]

Show Outcome Measure 1

2. Secondary:

Catheterizations Without Leakage [ Time Frame: 14 weeks ]

Show Outcome Measure 2

3. Secondary:

Urine Volume After First Awakening [ Time Frame: 14 weeks ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The transdermal groups included more males and younger subjects. The study was not designed to compare the transdermal and oral groups. Advserse event data reported for the titration and maintenance periods.

Results Point of Contact:

Name/Title: Gary Hoel, RPh, PhD, Executive Director of Clinical Research
Organization: Watson Laboratories, Inc
phone: 801-588-6641
e-mail: gary.hoel@watson.com

Publications of Results:

Cartwright PC, Coplen DE, Kogan BA, Volinn W, Finan E, Hoel G. Efficacy and safety of transdermal and oral oxybutynin in children with neurogenic detrusor overactivity. J Urol. 2009 Oct;182(4):1548-54. Epub 2009 Aug 15. Erratum in: J Urol. 2009 Dec;182(6):2985. Dosage error in article text.

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
Health Authority:	United States: Food and Drug Administration