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

• Sponsor: Watson Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00224016
• Collaborator: (none)
• Enrollment: 57
• Locations: 23
• Arms: 2
• Duration (Months): 45
• Patients Per Site: 2.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Detrusor Hyperreflexia	Drug: Oxybutynin; Drug: Oxybutynin	Phase 4

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.

Study Design

• Study Type: Interventional
• 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: Dec 1, 2004
• Actual Primary Completion Date: Apr 1, 2007
• Actual Study Completion Date: Sep 1, 2008

Arms and Interventions

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 Names: 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 Names: Ditropan, Ditropan XL, Oxybutynin

Outcome Measures

Primary Outcome Measures

1. Average Catheterization Urine Volume [14 weeks]

   Change from baseline in average volume of urine collected by catheterization

Secondary Outcome Measures

1. Catheterizations Without Leakage [14 weeks]

   Percentage of catherizations without leakage

2. Urine Volume After First Awakening [14 weeks]

   Change from baseline in average volume of urine collected after first morning awakening

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 15 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Watson Investigational Site	Little Rock	Arkansas	United States
2	Watson Investigational Site	Orange County	California	United States
3	Watson Investigational Site	San Diego	California	United States
4	Watson Investigational Site	Denver	Colorado	United States
5	Watson Investigational Site	Washington DC	District of Columbia	United States
6	Watson Investigational Site	Detroit	Michigan	United States
7	Watson Investigational Site	Mineapolis	Minnesota	United States
8	Watson Investigational Site	Jackson	Mississippi	United States
9	Watson Investigational Site	Kansas City	Missouri	United States
10	Watson Investigational Site	St. Louis	Missouri	United States
11	Watson Investigational Site	Voorhees	New Jersey	United States
12	Watson Investigational Site	Albany	New York	United States
13	Watson Investigational Site	Buffalo	New York	United States
14	Watson Investigational Site	Poughkeepsie	New York	United States
15	Watson Investigational Site	Ashville	North Carolina	United States
16	Watson Investigational Site	Durham	North Carolina	United States
17	Watson Investigational Site	Columbus	Ohio	United States
18	Watson Investigational Site	Oklahoma City	Oklahoma	United States
19	Watson Investigational Site	Hershy	Pennsylvania	United States
20	Watson Investigational Site	Dallas	Texas	United States
21	Watson Investigational Site	Houston	Texas	United States
22	Watson Investigational Site	Plano	Texas	United States
23	Watson Investigational Site	Salt Lake City	Utah	United States

Sponsors and Collaborators

• Watson Pharmaceuticals

Investigators

• Study Chair: Gary Hoel, RPh, PhD, Watson Laboratories, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Watson Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00224016
• Other Study ID Numbers: O03010
• First Posted: Sep 22, 2005
• Last Update Posted: Feb 9, 2012
• Last Verified: Feb 1, 2012

• Additional relevant MeSH terms: Reflex, Abnormal; Mandelic Acids; Oxybutynin

Study Results

Participant Flow

Arm/Group Title	Oxybutynin TDS	Oral Oxybutynin
Arm/Group Description	Oxybutynin Transdermal System	Oxybutynin tablets
Period Title: Titration Period
STARTED	39	16
COMPLETED	38	15
NOT COMPLETED	1	1
Period Title: Titration Period
STARTED	38	15
COMPLETED	36	14
NOT COMPLETED	2	1
Period Title: Titration Period
STARTED	35	0
COMPLETED	35	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Oxybutynin TDS	Oral Oxybutynin	Total
Arm/Group Description	Oxybutynin Transdermal System	Oxybutynin tablets	Total of all reporting groups
Overall Participants	39	16	55
Age (Count of Participants)
<=18 years	39 100%	16 100%	55 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	10.2 (2.64)	11.8 (2.82)	10.6 (2.76)
Sex: Female, Male (Count of Participants)
Female	17 43.6%	11 68.8%	28 50.9%
Male	22 56.4%	5 31.3%	27 49.1%
Region of Enrollment (participants) [Number]
United States	39 100%	16 100%	55 100%

Outcome Measures

1. Primary Outcome

Title	Average Catheterization Urine Volume
Description	Change from baseline in average volume of urine collected by catheterization
Time Frame	14 weeks

Outcome Measure Data

Analysis Population Description

Modified intent-to-treat (mITT) population, Last Observation Carried Forward (LOCF) imputation

Arm/Group Title	Oxybutynin TDS	Oral Oxybutynin
Arm/Group Description	Oxybutynin Transdermal System	Oxybutynin tablets
Measure Participants	38	14
Baseline Catheterization Volume	95.3 (63.88)	114.0 (74.67)
Change from Baseline in Cath Volume	30.0 (46.20)	52.4 (50.45)

2. Secondary Outcome

Title	Catheterizations Without Leakage
Description	Percentage of catherizations without leakage
Time Frame	14 weeks

Outcome Measure Data

Analysis Population Description

mITT, LOCF

Arm/Group Title	Oxybutynin TDS	Oral Oxybutynin
Arm/Group Description	Oxybutynin Transdermal System	Oxybutynin tablets
Measure Participants	38	14
Baseline % Catheterizations without leakage	28.7 (34.85) 73.6%	38.1 (41.86) 238.1%
Endpoint % Catheterizations without leakage	53.8 (36.05) 137.9%	72.6 (26.44) 453.8%

3. Secondary Outcome

Title	Urine Volume After First Awakening
Description	Change from baseline in average volume of urine collected after first morning awakening
Time Frame	14 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Oxybutynin TDS		Oral Oxybutynin
Arm/Group Description	Oxybutynin Transdermal System		Oxybutynin tablets
All Cause Mortality
	Oxybutynin TDS		Oral Oxybutynin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Oxybutynin TDS		Oral Oxybutynin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/39 (15.4%)		3/16 (18.8%)
Cardiac disorders
Thrombophlebitis	0/39 (0%)	0	1/16 (6.3%)	1
Gastrointestinal disorders
Gastritis	1/39 (2.6%)	1	0/16 (0%)	0
General disorders
Allergic reaction	0/39 (0%)	0	1/16 (6.3%)	1
Worsening abdominal pain	0/39 (0%)	0	1/16 (6.3%)	1
Fever	1/39 (2.6%)	1	0/16 (0%)	0
Metabolism and nutrition disorders
Worsening dehydration	1/39 (2.6%)	1	0/16 (0%)	0
Musculoskeletal and connective tissue disorders
Tethered cord	1/39 (2.6%)	1	0/16 (0%)	0
Nervous system disorders
VP shunt malfunction	2/39 (5.1%)	2	1/16 (6.3%)	1
Skin and subcutaneous tissue disorders
Knee wound dehiscence	1/39 (2.6%)	2	0/16 (0%)	0
Other (Not Including Serious) Adverse Events
	Oxybutynin TDS		Oral Oxybutynin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	33/39 (84.6%)		12/16 (75%)
Gastrointestinal disorders
Vomiting	5/39 (12.8%)	5	1/16 (6.3%)	1
Constipation	4/39 (10.3%)	4	1/16 (6.3%)	1
Diarrhea	3/39 (7.7%)	4	0/16 (0%)	0
General disorders
Fever	6/39 (15.4%)	7	3/16 (18.8%)	4
Headache	7/39 (17.9%)	12	2/16 (12.5%)	3
Pain abdominal	3/39 (7.7%)	3	2/16 (12.5%)	2
Pain back	3/39 (7.7%)	6	1/16 (6.3%)	1
Pain	4/39 (10.3%)	7	2/16 (12.5%)	3
Infections and infestations
Urinary tract infection	6/39 (15.4%)	6	2/16 (12.5%)	2
Infection	7/39 (17.9%)	8	0/16 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pharyngitis	5/39 (12.8%)	5	1/16 (6.3%)	1
Rhinitis	3/39 (7.7%)	4	0/16 (0%)	0
Skin and subcutaneous tissue disorders
Rash	5/39 (12.8%)	5	1/16 (6.3%)	1
Pruritis	3/39 (7.7%)	3	0/16 (0%)	0
Skin ulcer	2/39 (5.1%)	2	1/16 (6.3%)	1

Limitations/Caveats

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.

More Information

Certain Agreements

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

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.