Detrusor HyperreflexiaPhase 4NCT00224029
A Study Evaluating Oxybutynin in Patients With Neurogenic Overactive Bladder Associated With a Neurological Condition
A Phase 4 study testing Oxybutynin transdermal system in people with Detrusor Hyperreflexia, run by Watson Pharmaceuticals at 6 sites in United States.
Trial summary
This study will evaluate the efficacy and safety of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in adults who have spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Detrusor Hyperreflexia
- What is being tested?
- Oxybutynin transdermal system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 6 sitesUnited States
- Study dates
- Dec 2004to May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age at day of consent;
- Is a male, or is a non-pregnant non-lactating female who is either of non-child-bearing potential, or is using adequate means of birth control;
- Has a h/o of urinary incontinence from neurogenic bladder of spinal cord injury etiology;
- Has impairment based on the American Spinal Injury Association (ASIA);
- Use clean intermittent catheterization;
- Has urinary incontinence between scheduled catheterization;
- Capable of understanding and complying with the protocol.
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;
- History of major lower urinary tract surgery, procedures;
- Has an active skin disorder, affecting TDS application site areas;
- Hypersensitivity to the investigational drug;
- Has participated in any study involving administration of an investigational compound within 30 days before this study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Atlanta, Georgia
Study site
Chapel Hill, North Carolina
Study site
Charlotte, North Carolina
Study site
Dallas, Texas
Study site
Houston, Texas
Study site
The Bronx, New York
About this study
Official title: A Multi-center, Open-label, Dose-titration Pilot Study Evaluating the Efficacy and Safety of Oxybutynin Transdermal Systems in Patients With Neurogenic Bladder Resulting From Spinal Cord Injury
This study will evaluate the efficacy and safety of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in adults who have spinal cord injury.
Read the detailed description
The Dose Titration Period began with a 3.9 mg/day or 7.8 mg/day as a starting dose after the completion of a 3-day diary for baseline evaluations, including urodynamic testing. The clean intermittent catheterization (CIC) frequency remained constant throughout the Dose Titration Period. The dose was adjusted every two weeks during the Dose Titration Period by increasing one dose level, at the investigator's discretion, based on the patient's symptoms. If a patient achieved complete continence and reported tolerable or absence of side effects, the patient was continued at that dose for the duration of the 8-week Titration Period. If a patient reported unacceptable side effects, the dose was reduced by one level. This reduced dose was considered the maximum tolerable dose for the patient and the patient continued at that dose for the duration of the 8-week Titration Period. The dose levels evaluated were 3.9 mg/day, 7.8 mg/day, 9.1 mg/day, and 11.7 mg/day. Of the 22 subjects in the modified intent-to-treat population evaluated for efficacy, 0 were in the 3.9 mg/day dose group, 3 were in the 7.8 mg/day dose group, 8 were in the 9.1 mg/day dose group, and 11 were in the 11.7 mg/day dose group.
- Conditions
- Detrusor Hyperreflexia
- Being tested
- Oxybutynin transdermal system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxybutynin transdermal systemDrug
Also called Oxytrol
3.9 mg/day, 7.8 mg/day, 9.1 mg/day or 11.7 mg/day transdermal per titration
| Study group | Role | What they receive |
|---|---|---|
| Oxybutynin transdermal system | Experimental | Oxybutynin transdermal system 3.9 mg/day, 7.8 mg/day, 9.1 mg/day or 11.7 mg/day dosing Receives: Drug: Oxybutynin transdermal system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Number of Catheterizations Without Leaking Per Day
Baseline in number of daily catheterizations without leaking per day as recorded in a 3-day urinary diary.
Measured: 8 weeks
Secondary outcomes (3)
Patch Adhesion
Measured: 8 weeks
Urodynamic Measurements
Measured: 8 weeks
Urinary Leakage and Catheterization Data
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionDec 2005
- Study completionMay 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Watson Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gary Hoel, RPh, PhD, Study director, Watson Laboratories, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00224029
- Sponsor's protocol ID
- OXY0401
- Status last verified
- Apr 2010
- First submitted
- 13 Sep 2005
- Last updated
- 30 Apr 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kennelly MJ, Lemack GE, Foote JE, Trop CS. Efficacy and safety of oxybutynin transdermal system in spinal cord injury patients with neurogenic detrusor overactivity and incontinence: an open-label, dose-titration study. Urology. 2009 Oct;74(4):741-5. doi: 10.1016/j.urology.2009.05.008. Epub 2009 Jul 22.
PubMed 19628264
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Dose-titration Pilot Study Evaluating the Efficacy and Safety of Oxybutynin Transdermal Systems in Patients With Neurogenic Bladder Resulting From Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT00224029
- Acronym / sponsor ID
- OXY0401
- Conditions
- Detrusor Hyperreflexia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Watson PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 30 Apr 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy and safety of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in adults who have spinal cord injury.
Detailed description
The Dose Titration Period began with a 3.9 mg/day or 7.8 mg/day as a starting dose after the completion of a 3-day diary for baseline evaluations, including urodynamic testing. The clean intermittent catheterization (CIC) frequency remained constant throughout the Dose Titration Period. The dose was adjusted every two weeks during the Dose Titration Period by increasing one dose level, at the investigator's discretion, based on the patient's symptoms. If a patient achieved complete continence and reported tolerable or absence of side effects, the patient was continued at that dose for the duration of the 8-week Titration Period. If a patient reported unacceptable side effects, the dose was reduced by one level. This reduced dose was considered the maximum tolerable dose for the patient and the patient continued at that dose for the duration of the 8-week Titration Period. The dose levels evaluated were 3.9 mg/day, 7.8 mg/day, 9.1 mg/day, and 11.7 mg/day. Of the 22 subjects in the modified intent-to-treat population evaluated for efficacy, 0 were in the 3.9 mg/day dose group, 3 were in the 7.8 mg/day dose group, 8 were in the 9.1 mg/day dose group, and 11 were in the 11.7 mg/day dose group.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxybutynin transdermal system | Experimental | Drug: Oxybutynin transdermal systemOxybutynin transdermal system 3.9 mg/day, 7.8 mg/day, 9.1 mg/day or 11.7 mg/day dosing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 18 years of age at day of consent;
- Is a male, or is a non-pregnant non-lactating female who is either of non-child-bearing potential, or is using adequate means of birth control;
- Has a h/o of urinary incontinence from neurogenic bladder of spinal cord injury etiology;
- Has impairment based on the American Spinal Injury Association (ASIA);
- Use clean intermittent catheterization;
Key exclusion criteria (6 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;
- History of major lower urinary tract surgery, procedures;
- Has an active skin disorder, affecting TDS application site areas;
- Hypersensitivity to the investigational drug;
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 transdermal systemAlso: Oxytrol3.9 mg/day, 7.8 mg/day, 9.1 mg/day or 11.7 mg/day transdermal per titration | Drug | Oxybutynin transdermal system |
Primary outcome
Average Number of Catheterizations Without Leaking Per Day
Time frame: 8 weeks
Baseline in number of daily catheterizations without leaking per day as recorded in a 3-day urinary diary.
3 secondary outcomes
Patch Adhesion
Time frame: 8 weeks
Urodynamic Measurements
Time frame: 8 weeks
Urinary Leakage and Catheterization Data
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19628264Kennelly MJ, Lemack GE, Foote JE, Trop CS. Efficacy and safety of oxybutynin transdermal system in spinal cord injury patients with neurogenic detrusor overactivity and incontinence: an open-label, dose-titration study. Urology. 2009 Oct;74(4):741-5. doi: 10.1016/j.urology.2009.05.008. Epub 2009 Jul 22.
Related trials for Detrusor Hyperreflexia
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
RecruitingPhase 2/3
Open-label, Long-term Safety, Efficacy, and Pharmacokinetics Study of Vibegron in Pediatric Subjects 2 Years to < 18 Years of Age With NDO and on CIC
Neurogenic Detrusor Overactivity
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 director
Watson Laboratories, Inc.
6 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 transdermal system in people with Detrusor Hyperreflexia, run by Watson Pharmaceuticals at 6 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 7 inclusion and 6 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 30 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 30 Apr 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?
Average Number of Catheterizations Without Leaking Per Day (time frame: 8 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 NCT00224029, 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 30 Apr 2010.