Detrusor HyperreflexiaPhase 4NCT00224016

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

A Phase 4 study testing Oxybutynin in people with Detrusor Hyperreflexia, run by Watson Pharmaceuticals at 23 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

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. Read more about this study

Who is it for?: Ages 6 to 15 years
Conditions the study is for: Detrusor Hyperreflexia
What is being tested?: Oxybutynin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 57 participants
Where: 23 sitesUnited States
Study dates: Dec 2004to Sep 2008
Phase: Phase 4
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 6 to 15 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

23 sites in 1 country.

City, postcode or hospital

23 sites in 1 country

United States23 sites

Watson Investigational Site
Albany, New York
Watson Investigational Site
Ashville, North Carolina
Watson Investigational Site
Buffalo, New York
Watson Investigational Site
Columbus, Ohio
Watson Investigational Site
Dallas, Texas
Watson Investigational Site
Denver, Colorado
Watson Investigational Site
Detroit, Michigan
Watson Investigational Site
Durham, North Carolina
Watson Investigational Site
Hershy, Pennsylvania
Watson Investigational Site
Houston, Texas
Watson Investigational Site
Jackson, Mississippi
Watson Investigational Site
Kansas City, Missouri
Watson Investigational Site
Little Rock, Arkansas
Watson Investigational Site
Minneapolis, Minnesota
Watson Investigational Site
Oklahoma City, Oklahoma
Watson Investigational Site
Orange County, California
Watson Investigational Site
Plano, Texas
Watson Investigational Site
Poughkeepsie, New York
Watson Investigational Site
Salt Lake City, Utah
Watson Investigational Site
San Diego, California
Watson Investigational Site
St Louis, Missouri
Watson Investigational Site
Voorhees Township, New Jersey
Watson Investigational Site
Washington D.C., District of Columbia

Other trials in United States

About this study

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

Read the 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.

Conditions: Detrusor Hyperreflexia
Being tested: Oxybutynin

What participants receive

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

OxybutyninDrug
Also called Oxytrol
1.3, 2.6, 3.9 mg/day transdermal
OxybutyninDrug
Also called Ditropan, Ditropan XL, Oxybutynin
5 to 15 mg/day immediate release or extended release tablets, or syrup

Study groups in NCT00224016
Study group	Role	What they receive
Oxybutynin Transdermal System	Experimental	Oxybutynin Transdermal System 1.3 mg/day, 2.6 mg/day, or 3.9 mg/day Receives: Drug: Oxybutynin
Oral oxybutynin	Active comparator	5 to 15 mg/day immediate release or extended release tablets, or syrup Receives: Drug: Oxybutynin

What is being measured

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

Average Catheterization Urine Volume
Change from baseline in average volume of urine collected by catheterization
Measured: 14 weeks

Secondary outcomes (2)

Catheterizations Without Leakage
Percentage of catherizations without leakage
Measured: 14 weeks
Urine Volume After First Awakening
Change from baseline in average volume of urine collected after first morning awakening
Measured: 14 weeks

Timeline

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

Dec 2004Sep 2008

First posted22 Sep 2005 (estimated)
Study startDec 2004
Primary completionApr 2007
Study completionSep 2008

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 (1)Papers the sponsor has linked to this study.
Other trials for Detrusor HyperreflexiaStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00224016
Sponsor's protocol ID: O03010
Status last verified: Feb 2012
First submitted: 13 Sep 2005
Last updated: 9 Feb 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Cartwright PC, Coplen DE, Kogan BA, Volinn W, Finan E, Hoel G. Efficacy and safety of transdermal and oral oxybutynin in children with neurogenic detrusor overactivity. J Urol. 2009 Oct;182(4):1548-54. doi: 10.1016/j.juro.2009.06.058. Epub 2009 Aug 15.
PubMed 19683731

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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Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury
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Dose Escalation Study of EG110A, Administered by Intradetrusor Injections to Adults With Neurogenic Detrusor Overactivity-related Incontinence Following Spinal Cord Injury Who Regularly Perform Clean Intermittent Catheterization
Neurogenic Detrusor Overactivity, Spinal Cord Injuries
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TTNS in SCI Patients With Neurogenic Detrusor Overactivity
Spinal Cord Injuries, Neurogenic Detrusor Overactivity
Not yet recruitingObservational study
The Predictive Value of Lower Extremity Hypertonia on Neurogenic Detrusor Overactivity After Spinal Cord Injury
Spinal Cord Injuries (SCI)
Not yet recruitingPhase 1/2
Device for Bladder Control for Men With SCI
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All Detrusor Hyperreflexia trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00224016
Acronym / sponsor ID: O03010
Conditions: Detrusor Hyperreflexia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: Watson PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Dec 2004
Primary completion: Apr 2007 (actual)
Study completion: Sep 2008 (actual)
First posted: 22 Sep 2005 (estimated)
Results: Posted 23 Dec 2009

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Oxybutynin Transdermal System	Experimental	Drug: OxybutyninOxybutynin Transdermal System 1.3 mg/day, 2.6 mg/day, or 3.9 mg/day
Oral oxybutynin	Active comparator	Drug: Oxybutynin5 to 15 mg/day immediate release or extended release tablets, or syrup

Who may qualify

Ages: 6 to 15 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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

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: Oxytrol1.3, 2.6, 3.9 mg/day transdermal	Drug	Oxybutynin Transdermal System
OxybutyninAlso: Ditropan, Ditropan XL, Oxybutynin5 to 15 mg/day immediate release or extended release tablets, or syrup	Drug	Oral oxybutynin

Primary outcome

Average Catheterization Urine Volume
Time frame: 14 weeks
Change from baseline in average volume of urine collected by catheterization

2 secondary outcomes

Catheterizations Without Leakage
Time frame: 14 weeks
Urine Volume After First Awakening
Time frame: 14 weeks

Results and safety

Results posted to the registry on 23 Dec 2009, 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 TDS	39	38
Oral Oxybutynin	16	15

Primary outcome: Average Catheterization Urine Volume

Time frame: 14 weeks. Mean (Standard Deviation). Unit: mL

Measure	Oxybutynin TDS n = 38	Oral Oxybutynin n = 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)

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

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oxybutynin TDS	6 of 39 (15.4%)	33 of 39 (84.6%)	Not reported
Oral Oxybutynin	3 of 16 (18.8%)	12 of 16 (75%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19683731Cartwright PC, Coplen DE, Kogan BA, Volinn W, Finan E, Hoel G. Efficacy and safety of transdermal and oral oxybutynin in children with neurogenic detrusor overactivity. J Urol. 2009 Oct;182(4):1548-54. doi: 10.1016/j.juro.2009.06.058. Epub 2009 Aug 15.

Related trials for Detrusor Hyperreflexia

Recruiting
Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury
Spinal Cord Injury, Acute
RecruitingPhase 1/2
Dose Escalation Study of EG110A, Administered by Intradetrusor Injections to Adults With Neurogenic Detrusor Overactivity-related Incontinence Following Spinal Cord Injury Who Regularly Perform Clean Intermittent Catheterization
Neurogenic Detrusor Overactivity, Spinal Cord Injuries
Not yet recruiting
TTNS in SCI Patients With Neurogenic Detrusor Overactivity
Spinal Cord Injuries, Neurogenic Detrusor Overactivity
Not yet recruitingObservational study
The Predictive Value of Lower Extremity Hypertonia on Neurogenic Detrusor Overactivity After Spinal Cord Injury
Spinal Cord Injuries (SCI)
Not yet recruitingPhase 1/2
Device for Bladder Control for Men With SCI
Neurogenic Bladder

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.

Gary Hoel, RPh, PhD study chair

Watson Laboratories, Inc.

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Oxybutynin in people with Detrusor Hyperreflexia, run by Watson Pharmaceuticals at 23 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 3 inclusion and 2 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 9 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 23 Dec 2009). 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?

Average Catheterization Urine Volume (time frame: 14 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 NCT00224016, which also lists 1 linked publication.

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 9 Feb 2012.