Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence

• Sponsor: Antares Pharma Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00909181
• Collaborator: (none)
• Enrollment: 626
• Locations: 55
• Arms: 3
• Duration (Months): 20
• Patients Per Site: 11.4
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The primary objective of the double-blind phase of the study is to compare the effects of two doses of oxybutynin gel to placebo gel. The objective of the open-label extension is to evaluate the extended safety and skin-irritation profile of topically administered oxybutynin gel.

The hypothesis is that topically administered oxybutynin gel will decrease (compared to placebo) the number of incontinence episodes per week, average daily urinary frequency, and urinary urgency; increase average urinary void volume; and improve patient quality of life.

Condition or Disease	Intervention/Treatment	Phase
Urge Urinary Incontinence; Urinary Frequency	Drug: Oxybutynin; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 626 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Double-Blind, Randomized, Parallel, Placebo-Controlled, Multicenter Study Evaluating the Effect of Treatment With Topically Administered Oxybutynin Gel in Patients With Urinary Frequency, and Urge and Mixed Urinary Incontinence With a Predominance of Urge Incontinence Episodes With an Open-Label Extension
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Oxybutynin Gel 56 mg/day	Drug: Oxybutynin; Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment. Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo; Other Names: Anturol; Oxybutynin Gel 3% ; Drug: Placebo; Placebo Gel Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment. Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo; Other Names: Anturol; Oxybutynin Gel 3%
Experimental: Oxybutynin Gel 84 mg/day	Drug: Oxybutynin; Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment. Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo; Other Names: Anturol; Oxybutynin Gel 3% ; Drug: Placebo; Placebo Gel Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment. Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo; Other Names: Anturol; Oxybutynin Gel 3%
Placebo Comparator: Placebo Gel	Drug: Oxybutynin; Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment. Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo; Other Names: Anturol; Oxybutynin Gel 3% ; Drug: Placebo; Placebo Gel Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment. Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo; Other Names: Anturol; Oxybutynin Gel 3%

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12 [12 weeks]

   Reduction in number of incontinent episodes, evaluated as mITT (modified intention to treat), after 12 weeks of treatment compared to baseline.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Overactive bladder (OAB) symptoms of urge and/or mixed UI with a predominance of urge incontinence for at least 3 months

• Have a history of at least 1 - 2 urge episodes and 8 or more voids per day

Exclusion Criteria:

• Incontinence that is predominantly stress, insensate, or overflow in nature, or incontinence related to chronic illness, anatomical weakness/abnormalities or concomitant medications

• PVR volume > 200 mL or relative PVR > 50% of pre-void volume as determined by bladder ultrasound

• History of urinary retention, gastric retention, or uncontrollable narrow-angle glaucoma, or patients who are at risk for these conditions

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Birmingham	Alabama	United States	35233
2		Little Rock	Arkansas	United States	72211
3		Laguna Hills	California	United States	92653
4		Los Angeles	California	United States	90048
5		San Diego	California	United States	92103
6		San Diego	California	United States	92120
7		Farmington	Connecticut	United States	06032
8		New Britain	Connecticut	United States	06052
9		N. Miami	Florida	United States	33161
10		New Port Richey	Florida	United States	34625
11		Pembroke Pines	Florida	United States	33024
12		Sarasota	Florida	United States	34232
13		St. Petersburg	Florida	United States	33710
14		Tampa	Florida	United States	33607
15		Wellington	Florida	United States	33414
16		Columbus	Georgia	United States	31904
17		Sandy Springs	Georgia	United States	30328
18		Stockbridge	Georgia	United States	30281
19		Evanston	Illinois	United States	60201
20		West Des Moines	Iowa	United States	50266
21		Shreveport	Louisiana	United States	71106
22		Annapolis	Maryland	United States	21401
23		Towson	Maryland	United States	21204
24		Watertown	Massachusetts	United States	02472
25		Grand Rapids	Michigan	United States	49503
26		Saginaw	Michigan	United States	48604
27		Chesterfield	Missouri	United States	63017
28		Las Vegas	Nevada	United States	89130
29		Brooklyn	New York	United States	11211
30		Endwell	New York	United States	13760
31		Kingston	New York	United States	12401
32		Poughkeepsie	New York	United States	12601
33		Williamsville	New York	United States	14221
34		Cary	North Carolina	United States	27518
35		Charlotte	North Carolina	United States	28209
36		Harrisburg	North Carolina	United States	28075
37		Raleigh	North Carolina	United States	27607
38		Raleigh	North Carolina	United States	27609
39		Salisbury	North Carolina	United States	28144
40		Wilmington	North Carolina	United States	28401
41		Winston-Salem	North Carolina	United States	27103
42		Wadsworth	Ohio	United States	44218
43		Bethany	Oklahoma	United States	73008
44		Corvallis	Oregon	United States	97330
45		Bala Cynwyd	Pennsylvania	United States	19004
46		Landsdale	Pennsylvania	United States	19446
47		Greenville	South Carolina	United States	29615
48		Mount Pleasant	South Carolina	United States	29464
49		Myrtle Beach	South Carolina	United States	29572
50		Sioux Falls	South Dakota	United States	57104
51		Fayetteville	Tennessee	United States	37334
52		Provo	Utah	United States	84604
53		Richmond	Virginia	United States	23294
54		Seattle	Washington	United States	98104
55		Spokane	Washington	United States	99207

Sponsors and Collaborators

• Antares Pharma Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Antares Pharma Inc.
• ClinicalTrials.gov Identifier: NCT00909181
• Other Study ID Numbers: 20070060
• First Posted: May 27, 2009
• Last Update Posted: Jul 2, 2014
• Last Verified: Jun 1, 2014

• Additional relevant MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Urge; Mandelic Acids; Oxybutynin

Study Results

Participant Flow

Recruitment Details	Recruitment in clinical sites (urologists mainly) started in September 2007 and was terminated in February 2010.
Pre-assignment Detail	Baseline period was 1 week. Patients on OAB drugs had to wash out.

Arm/Group Title	Oxybutynin Gel 56 mg/Day	Oxybutynin Gel 84 mg/Day	Placebo Gel
Arm/Group Description
Period Title: Overall Study
STARTED	210	214	202
COMPLETED	171	196	169
NOT COMPLETED	39	18	33

Baseline Characteristics

Arm/Group Title	Oxybutynin Gel 56 mg/Day	Oxybutynin Gel 84 mg/Day	Placebo Gel	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	210	214	202	626
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	120 57.1%	122 57%	120 59.4%	362 57.8%
>=65 years	90 42.9%	92 43%	82 40.6%	264 42.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.4 (12.6)	59.1 (13.3)	57.8 (13.3)	58.8 (13.1)
Sex: Female, Male (Count of Participants)
Female	182 86.7%	182 85%	178 88.1%	542 86.6%
Male	28 13.3%	32 15%	24 11.9%	84 13.4%
Region of Enrollment (participants) [Number]
United States	210 100%	214 100%	202 100%	626 100%
Number of incontinent episodes at baseline (Episodes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Episodes]	50.1 (32.5)	43.6 (27.5)	45.8 (28.9)	46.5 (29.3)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12
Description	Reduction in number of incontinent episodes, evaluated as mITT (modified intention to treat), after 12 weeks of treatment compared to baseline.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

mITT (modified intended to treatment) per protocol Difference between Baseline and after 12 weeks treatment

Arm/Group Title	Oxybutynin Gel 56 mg/Day	Oxybutynin Gel 84 mg/Day	Placebo Gel
Arm/Group Description
Measure Participants	175	191	166
Mean (Standard Deviation) [Episodes]	-24.8 (28.7)	-21.9 (25.1)	-20.0 (27.0)

Adverse Events

Time Frame	Throughout whole study (20 months)
Arm/Group Title	Oxybutynin Gel 56 mg/Day		Oxybutynin Gel 84 mg/Day		Placebo Gel
Arm/Group Description
All Cause Mortality
	Oxybutynin Gel 56 mg/Day		Oxybutynin Gel 84 mg/Day		Placebo Gel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Oxybutynin Gel 56 mg/Day		Oxybutynin Gel 84 mg/Day		Placebo Gel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/210 (1.4%)		4/214 (1.9%)		2/202 (1%)
Blood and lymphatic system disorders
Sickle cell anaemia with crisis	0/210 (0%)	0	0/214 (0%)	0	1/202 (0.5%)	1
Cardiac disorders
Angina pectoris	1/210 (0.5%)	1	0/214 (0%)	0	0/202 (0%)	0
Hepatobiliary disorders
Hepatic neoplasm malignant	1/210 (0.5%)	1	0/214 (0%)	0	0/202 (0%)	0
Injury, poisoning and procedural complications
Fibula fracture	0/210 (0%)	0	1/214 (0.5%)	1	0/202 (0%)	0
Meniscus lesion	0/210 (0%)	0	1/214 (0.5%)	1	0/202 (0%)	0
Musculoskeletal and connective tissue disorders
Abdominal pain	1/210 (0.5%)	1	0/214 (0%)	0	0/202 (0%)	0
Chest pain	0/210 (0%)	0	1/214 (0.5%)	1	0/202 (0%)	0
Reproductive system and breast disorders
Abortion missed	0/210 (0%)	0	1/214 (0.5%)	1	0/202 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pneumonia	0/210 (0%)	0	1/214 (0.5%)	1	2/202 (1%)	2
Other (Not Including Serious) Adverse Events
	Oxybutynin Gel 56 mg/Day		Oxybutynin Gel 84 mg/Day		Placebo Gel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	98/210 (46.7%)		90/214 (42.1%)		53/202 (26.2%)
Gastrointestinal disorders
Dry mouth	23/210 (11%)		26/214 (12.1%)		10/202 (5%)
Constipation	3/210 (1.4%)		8/214 (3.7%)		5/202 (2.5%)
Diarrhoe	5/210 (2.4%)		2/214 (0.9%)		1/202 (0.5%)
General disorders
Application site erythema	8/210 (3.8%)		8/214 (3.7%)		2/202 (1%)
Application site rash	9/210 (4.3%)		7/214 (3.3%)		1/202 (0.5%)
Application site pruritus	3/210 (1.4%)		6/214 (2.8%)		1/202 (0.5%)
Infections and infestations
Urinary tract infection	9/210 (4.3%)		6/214 (2.8%)		4/202 (2%)
Nasopharyngitis	5/210 (2.4%)		5/214 (2.3%)		0/202 (0%)
Sinusitis	5/210 (2.4%)		3/214 (1.4%)		2/202 (1%)
Musculoskeletal and connective tissue disorders
Back pain	5/210 (2.4%)		2/214 (0.9%)		5/202 (2.5%)
Nervous system disorders
Headache	6/210 (2.9%)		6/214 (2.8%)		8/202 (4%)
Dizziness	6/210 (2.9%)		2/214 (0.9%)		4/202 (2%)
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection	6/210 (2.9%)		6/214 (2.8%)		10/202 (5%)
Skin and subcutaneous tissue disorders
Application site reaction	5/210 (2.4%)		3/214 (1.4%)		0/202 (0%)

Limitations/Caveats

[Not Specified]

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.