Urge Urinary IncontinencePhase 3NCT00909181

Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence

A Phase 3 study testing Oxybutynin in people with Urge Urinary Incontinence and Urinary Frequency, run by Antares Pharma Inc. at 55 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Urge Urinary Incontinence, Urinary Frequency
What is being tested?: Oxybutynin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 626 participants
Where: 55 sitesUnited States
Study dates: Mar 2009to Nov 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

55 sites in 1 country.

City, postcode or hospital

55 sites in 1 country

United States55 sites

Study site
Annapolis, Maryland, 21401
Study site
Bala-Cynwyd, Pennsylvania, 19004
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Bethany, Oklahoma, 73008
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Birmingham, Alabama, 35233
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Brooklyn, New York, 11211
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Cary, North Carolina, 27518
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Charlotte, North Carolina, 28209
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Chesterfield, Missouri, 63017
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Columbus, Georgia, 31904
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Corvallis, Oregon, 97330
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Endwell, New York, 13760
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Evanston, Illinois, 60201
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Farmington, Connecticut, 06032
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Fayetteville, Tennessee, 37334
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Grand Rapids, Michigan, 49503
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Greenville, South Carolina, 29615
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Harrisburg, North Carolina, 28075
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Kingston, New York, 12401
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Laguna Hills, California, 92653
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Landsdale, Pennsylvania, 19446
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Las Vegas, Nevada, 89130
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Little Rock, Arkansas, 72211
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Los Angeles, California, 90048
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Mt. Pleasant, South Carolina, 29464
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Myrtle Beach, South Carolina, 29572
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New Britain, Connecticut, 06052
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New Port Richey, Florida, 34625
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North Miami, Florida, 33161
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Pembroke Pines, Florida, 33024
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Poughkeepsie, New York, 12601
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Provo, Utah, 84604
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Raleigh, North Carolina, 27607
Study site
Raleigh, North Carolina, 27609
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Richmond, Virginia, 23294
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Saginaw, Michigan, 48604
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Salisbury, North Carolina, 28144
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San Diego, California, 92103
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San Diego, California, 92120
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Sandy Springs, Georgia, 30328
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Sarasota, Florida, 34232
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Seattle, Washington, 98104
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Shreveport, Louisiana, 71106
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Sioux Falls, South Dakota, 57104
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Spokane, Washington, 99207
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St. Petersburg, Florida, 33710
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Stockbridge, Georgia, 30281
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Tampa, Florida, 33607
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Towson, Maryland, 21204
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Wadsworth, Ohio, 44218
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Watertown, Massachusetts, 02472
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Wellington, Florida, 33414
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West Des Moines, Iowa, 50266
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Williamsville, New York, 14221
Study site
Wilmington, North Carolina, 28401
Study site
Winston-Salem, North Carolina, 27103

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About this study

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

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.

Conditions: Urge Urinary Incontinence, Urinary Frequency
Being tested: Oxybutynin, Placebo
Medical subject headings: Urinary Incontinence, Urge

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OxybutyninDrug
Also called Anturol; Oxybutynin Gel 3%
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
PlaceboDrug
Also called Anturol; Oxybutynin Gel 3%
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

Study groups in NCT00909181
Study group	Role	What they receive
Oxybutynin Gel 56 mg/day	Experimental	Not described Receives: Drug: Oxybutynin; Drug: Placebo
Oxybutynin Gel 84 mg/day	Experimental	Not described Receives: Drug: Oxybutynin; Drug: Placebo
Placebo Gel	Placebo comparator	Not described Receives: Drug: Oxybutynin; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Nov 2010

First posted27 May 2009 (estimated)
Study startMar 2009
Primary completionJul 2010
Study completionNov 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Urge Urinary IncontinenceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 626 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00909181
Sponsor's protocol ID: 20070060
Status last verified: Jun 2014
First submitted: 25 May 2009
Last updated: 2 Jul 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00909181
Acronym / sponsor ID: 20070060
Conditions: Urge Urinary Incontinence, Urinary Frequency
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 626 participants (actual)
Lead sponsor: Antares Pharma Inc.Industry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: Jul 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 27 May 2009 (estimated)
Results: Posted 19 Jan 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Oxybutynin Gel 56 mg/day	Experimental	Drug: Oxybutynin, Drug: Placebo
Oxybutynin Gel 84 mg/day	Experimental	Drug: Oxybutynin, Drug: Placebo
Placebo Gel	Placebo comparator	Drug: Oxybutynin, Drug: Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OxybutyninAlso: Anturol; Oxybutynin Gel 3%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	Drug	Oxybutynin Gel 56 mg/day, Oxybutynin Gel 84 mg/day, Placebo Gel
PlaceboAlso: Anturol; Oxybutynin Gel 3%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	Drug	Oxybutynin Gel 56 mg/day, Oxybutynin Gel 84 mg/day, Placebo Gel

Primary outcome

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

Results and safety

Results posted to the registry on 19 Jan 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oxybutynin Gel 56 mg/Day	210	171
Oxybutynin Gel 84 mg/Day	214	196
Placebo Gel	202	169

Primary outcome: Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12

Time frame: 12 weeks. Mean (Standard Deviation). Unit: Episodes

Measure	Oxybutynin Gel 56 mg/Day n = 175	Oxybutynin Gel 84 mg/Day n = 191	Placebo Gel n = 166
Value	-24.8 (28.7)	-21.9 (25.1)	-20.0 (27.0)

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

Adverse events

Time frame: Throughout whole study (20 months). Other adverse events reported at 2.5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oxybutynin Gel 56 mg/Day	3 of 210 (1.4%)	98 of 210 (46.7%)	Not reported
Oxybutynin Gel 84 mg/Day	4 of 214 (1.9%)	90 of 214 (42.1%)	Not reported
Placebo Gel	2 of 202 (1%)	53 of 202 (26.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

55 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Oxybutynin in people with Urge Urinary Incontinence and Urinary Frequency, run by Antares Pharma Inc. at 55 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00909181.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2014.