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Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence

Primary Purpose

Urge Urinary Incontinence, Urinary Frequency

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Oxybutynin
Placebo
Sponsored by
Antares Pharma Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urge Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Oxybutynin Gel 56 mg/day

Oxybutynin Gel 84 mg/day

Placebo Gel

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 25, 2009
Last Updated
June 23, 2014
Sponsor
Antares Pharma Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00909181
Brief Title
Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence
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 Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Antares Pharma Inc.

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urge Urinary Incontinence, Urinary Frequency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
626 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxybutynin Gel 56 mg/day
Arm Type
Experimental
Arm Title
Oxybutynin Gel 84 mg/day
Arm Type
Experimental
Arm Title
Placebo Gel
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Oxybutynin
Other Intervention Name(s)
Anturol; Oxybutynin Gel 3%
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Anturol; Oxybutynin Gel 3%
Intervention Description
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
Primary Outcome Measure Information:
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06052
Country
United States
City
N. Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34625
Country
United States
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89130
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11211
Country
United States
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
City
Kingston
State/Province
New York
ZIP/Postal Code
12401
Country
United States
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
City
Harrisburg
State/Province
North Carolina
ZIP/Postal Code
28075
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Wadsworth
State/Province
Ohio
ZIP/Postal Code
44218
Country
United States
City
Bethany
State/Province
Oklahoma
ZIP/Postal Code
73008
Country
United States
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
City
Bala Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
City
Landsdale
State/Province
Pennsylvania
ZIP/Postal Code
19446
Country
United States
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
City
Fayetteville
State/Province
Tennessee
ZIP/Postal Code
37334
Country
United States
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99207
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence

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