Overactive BladderPhase 3NCT00350636

A Comparison of a New Drug to Treat Overactive Bladder vs. Placebo

A Phase 3 study testing Oxybutynin topical gel in people with Overactive Bladder, run by Watson Pharmaceuticals at 63 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

A new drug for overactive bladder is compared to placebo to determine if it is safe and effective. The study lasts approximately 12 weeks. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Overactive Bladder
What is being tested?: Oxybutynin topical gel
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 789 participants
Where: 63 sitesUnited States
Study dates: Jun 2006to May 2007
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

Females and males, 18 years of older with overactive bladder symptoms

Who cannot join

Treatable conditions that may cause urinary incontinence
Medical conditions in which it would be unsafe to use an anti-cholinergic agent.
The use of concomitant drugs that would confound the efficacy evaluation.
The use of concomitant drugs that would be unsafe with an anti-cholinergic agent.

Trial locations and contacts

63 sites in 1 country.

City, postcode or hospital

63 sites in 1 country

United States63 sites

Study site
Albany, New York
Study site
Albuquerque, New Mexico
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Allentown, Pennsylvania
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Alpharetta, Georgia
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Anaheim, California
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Atlanta, Georgia
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Austin, Texas
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Aventura, Florida
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Belville, Illinois
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Bethany, Oklahoma
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Birmingham, Alabama
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Buena Park, California
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Chicago, Illinois
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Clearwater, Florida
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Cleveland, Ohio
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Columbus, Ohio
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Corpus Christi, Texas
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Dallas, Texas
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DeLand, Florida
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Denver, Colorado
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Edmond, Oklahoma
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Evansville, Indiana
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Garden City, New York
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Greer, South Carolina
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Homewood, Alabama
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Houston, Texas
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Laguna Woods, California
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Las Vegas, Nevada
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Leesburg, Florida
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Little Rock, Arkansas
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Lyndhurst, Ohio
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Melrose Park, Illinois
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Mobile, Alabama
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Montgomery, Alabama
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Nashville, Tennessee
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New York, New York
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Newton, Pennsylvania
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Ocala, Florida
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Omaha, Nebraska
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Philadelphia, Pennsylvania
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Phoenix, Arizona
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Plantation, Florida
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Portland, Oregon
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Richmond, Virginia
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Sacramento, California
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Saginaw, Michigan
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Saint Joseph, Michigan
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Salt Lake City, Utah
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San Antonio, Texas
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San Diego, California
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Shreveport, Louisiana
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South Bend, Indiana
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Spokane, Washington
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Tallahassee, Florida
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Torrance, California
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Tucson, Arizona
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Warwick, Rhode Island
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Waterbury, Connecticut
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Watertown, Massachusetts
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West Palm Beach, Florida
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West Reading, Pennsylvania
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Williamsville, New York
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Winston-Salem, North Carolina

Other trials in United States

About this study

Official title: Multi-Center, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Daily Dosing With Oxybutynin Topical Gel to Treat the Symptoms of Overactive Bladder With a 14-Week Open-Label Safety Extension

A new drug for overactive bladder is compared to placebo to determine if it is safe and effective. The study lasts approximately 12 weeks.

Conditions: Overactive Bladder
Being tested: Oxybutynin topical gel, Placebo topical gel
Keywords: OAB, anticholineric, oxybutynin, urge urinary incontinence
Medical subject headings: Urinary Bladder, Overactive, Urinary Incontinence, Urge

What participants receive

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

Oxybutynin topical gelDrug
Also called Oxybutynin
1 application daily to skin for 12 weeks
Placebo topical gelOther
Also called Placebo
1 application daily to skin for 12 weeks

Study groups in NCT00350636
Study group	Role	What they receive
Oxybutynin topical gel	Experimental	Oxybutynin topical gel Receives: Drug: Oxybutynin topical gel
Placebo topical gel	Placebo comparator	placebo topical gel Receives: Other: Placebo topical gel

What is being measured

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

Baseline Average Number of Daily Incontinence Episodes
Average number of daily incontinence episodes at baseline
Measured: Baseline
Change From Baseline in Average Daily Number of Incontinence Episodes
Change from Baseline to Week 12 in average daily number of incontinence episodes
Measured: Baseline to Week 12

Secondary outcomes (4)

Baseline Average Daily Urinary Frequency
Number of daily urinary voids
Measured: Baseline
Change From Baseline in Average Daily Urinary Frequency
Change from baseline in average daily urinary frequency
Measured: Baseline to 12 weeks
Baseline Average Urine Void Volume
Baseline average urine void volume
Measured: Baseline
Change From Baseline in Average Urine Void Volume
Change from baseline to Week 12 in average urine void volume
Measured: Change from Baseline to Week 12

Timeline

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

Jun 2006May 2007

First posted11 Jul 2006 (estimated)
Study startJun 2006
Primary completionMay 2007
Study completionMay 2007

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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Overactive BladderStudies 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 789 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00350636
Sponsor's protocol ID: OG05009
Status last verified: Apr 2010
First submitted: 10 Jul 2006
Last updated: 10 May 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Staskin DR, Dmochowski RR, Sand PK, Macdiarmid SA, Caramelli KE, Thomas H, Hoel G. Efficacy and safety of oxybutynin chloride topical gel for overactive bladder: a randomized, double-blind, placebo controlled, multicenter study. J Urol. 2009 Apr;181(4):1764-72. doi: 10.1016/j.juro.2008.11.125. Epub 2009 Feb 23.
PubMed 19233423
Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
PubMed 37160401

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

Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)

All Overactive Bladder trials

Study at a glance

From the registry record, last updated by the sponsor on 10 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-Center, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Daily Dosing With Oxybutynin Topical Gel to Treat the Symptoms of Overactive Bladder With a 14-Week Open-Label Safety Extension
ClinicalTrials.gov ID: NCT00350636
Acronym / sponsor ID: OG05009
Conditions: Overactive Bladder
Keywords: OAB, anticholineric, oxybutynin, urge urinary incontinence
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 789 participants (actual)
Lead sponsor: Watson PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jun 2006
Primary completion: May 2007 (actual)
Study completion: May 2007 (actual)
First posted: 11 Jul 2006 (estimated)
Results: Posted 10 May 2010

Clinical summary

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

A new drug for overactive bladder is compared to placebo to determine if it is safe and effective. The study lasts approximately 12 weeks.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Oxybutynin topical gel	Experimental	Drug: Oxybutynin topical gelOxybutynin topical gel
Placebo topical gel	Placebo comparator	Other: Placebo topical gelplacebo topical gel

Who may qualify

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

Key inclusion criteria (1 listed)

Females and males, 18 years of older with overactive bladder symptoms

Key exclusion criteria (4 listed)

Treatable conditions that may cause urinary incontinence
Medical conditions in which it would be unsafe to use an anti-cholinergic agent.
The use of concomitant drugs that would confound the efficacy evaluation.
The use of concomitant drugs that would be unsafe with an anti-cholinergic agent.

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
Oxybutynin topical gelAlso: Oxybutynin1 application daily to skin for 12 weeks	Drug	Oxybutynin topical gel
Placebo topical gelAlso: Placebo1 application daily to skin for 12 weeks	Other	Placebo topical gel

Primary outcome

Baseline Average Number of Daily Incontinence Episodes
Time frame: Baseline
Average number of daily incontinence episodes at baseline
Change From Baseline in Average Daily Number of Incontinence Episodes
Time frame: Baseline to Week 12
Change from Baseline to Week 12 in average daily number of incontinence episodes

4 secondary outcomes

Baseline Average Daily Urinary Frequency
Time frame: Baseline
Change From Baseline in Average Daily Urinary Frequency
Time frame: Baseline to 12 weeks
Baseline Average Urine Void Volume
Time frame: Baseline
Change From Baseline in Average Urine Void Volume
Time frame: Change from Baseline to Week 12

Results and safety

Results posted to the registry on 10 May 2010, 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 Topical Gel	389	346
Placebo Topical Gel	400	355

Primary outcome: Baseline Average Number of Daily Incontinence Episodes

Time frame: Baseline. Mean (Standard Deviation). Unit: Number of episodes

Measure	Oxybutynin Topical Gel n = 389	Placebo Topical Gel n = 400
Value	5.4 (3.26)	5.4 (3.28)

Primary outcome: Change From Baseline in Average Daily Number of Incontinence Episodes

Time frame: Baseline to Week 12. Mean (Standard Deviation). Unit: Number of episodes

Measure	Oxybutynin Topical Gel n = 389	Placebo Topical Gel n = 400
Value	-3.0 (2.73)	-2.5 (3.06)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oxybutynin Topical Gel	7 of 389 (1.8%)	176 of 389 (45.2%)	Not reported
Placebo Topical Gel	10 of 400 (2.5%)	145 of 400 (36.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19233423Staskin DR, Dmochowski RR, Sand PK, Macdiarmid SA, Caramelli KE, Thomas H, Hoel G. Efficacy and safety of oxybutynin chloride topical gel for overactive bladder: a randomized, double-blind, placebo controlled, multicenter study. J Urol. 2009 Apr;181(4):1764-72. doi: 10.1016/j.juro.2008.11.125. Epub 2009 Feb 23.
Derived from this study: PubMed 37160401Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
Drugs@FDALink provided by the sponsor.
Watson Pharma product webpageLink provided by the sponsor.

Related trials for Overactive Bladder

Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)

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.

Kim Caramelli, MS study director

Watson Pharmaceuticals

63 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 topical gel in people with Overactive Bladder, run by Watson Pharmaceuticals at 63 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 1 inclusion and 4 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 10 May 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 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 10 May 2010). 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?

Baseline Average Number of Daily Incontinence Episodes (time frame: Baseline). The study lists 2 primary outcomes in all. 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 NCT00350636, which also lists 2 linked publications.

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 10 May 2010.