Overactive DetrusorPhase 4NCT01192568
Safety and Efficacy Evaluation of Oxybutynin Topical Gel In Children With Neurogenic Bladder
A Phase 4 study testing Oxybutynin in people with Overactive Detrusor and Neurogenic Bladder, run by AbbVie at 10 sites in United States.
Trial summary
This study will evaluate the safety and efficacy of Oxybutynin Chloride 10% Topical Gel in children 3 to less than 17 years old, who have overactive bladder due to a neurogenic condition. Children will be treated with 0.75 g of gel/day for two weeks. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Overactive Detrusor, Neurogenic Bladder
- What is being tested?
- Oxybutynin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 10 sitesUnited States
- Study dates
- 17 May 2011to 24 Oct 2023
- 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 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 3 years to < 17 years
- Neurogenic bladder
- Neurological condition
- CIC
Who cannot join
- Have anatomical bladder abnormalities
- Sensitivity to anticholinergics
- Bladder augmentation
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Albany Medical College /ID# 236880
Albany, New York, 12208
Augusta University Medical Center /ID# 238188
Augusta, Georgia, 30912-0004
Children's Hospital Colorado - Aurora /ID# 237620
Aurora, Colorado, 80045
Duke University /ID# 237494
Durham, North Carolina, 27710
Cook Children's Med. Center /ID# 237538
Fort Worth, Texas, 76104
University of Mississippi Medical Center /ID# 238065
Jackson, Mississippi, 39216-4500
Loma Linda University /ID# 236889
Loma Linda, California, 92354
Child Hosp of the King's Dtr's /ID# 237799
Norfolk, Virginia, 23507
Child Hosp of Orange County,CA /ID# 237517
Orange, California, 92868
Duplicate_Oregon Health & Science University /ID# 234354
Portland, Oregon, 97239-3011
About this study
Official title: A Two-part, Multicenter, Dose-titration Study Evaluating the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of Oxybutynin Chloride 10% Gel for the Treatment of Detrusor Overactivity Associated With a Neurological Condition in Pediatric Patients
This study will evaluate the safety and efficacy of Oxybutynin Chloride 10% Topical Gel in children 3 to less than 17 years old, who have overactive bladder due to a neurogenic condition. Children will be treated with 0.75 g of gel/day for two weeks. Patients will then return to the clinic for a potential dose titration. At this time their dose may be adjusted up to 1g/day, down to 0.5g/day, or remain the same at 0.75g of gel/day depending on the individual response and tolerability. The total treatment time is 14 weeks and total time on the study is 16 weeks.
Read the detailed description
This study will use a two-part, multicenter, dose-titration study in pediatric patients with a detrusor overactivity associated with a neurological condition
- Conditions
- Overactive Detrusor, Neurogenic Bladder
- Being tested
- Oxybutynin, Placebo
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxybutyninDrug
Also called Gelnique
10% Oxybutynin Chloride Topical Gel, 0.5 g, 0.75 g, and 1 g/day, administered transdermally.
PlaceboDrug
Topical gel
| Study group | Role | What they receive |
|---|---|---|
| DB: OTG (Pre-Amend 3) | Experimental | Double-Blind Oxybutynin Chloride topical gel (OTG) (Pre-Amendment 3) Oxybutynin Chloride topical gel (OTG), 0.5 g, 0.75 g (starting dose), or 1 g sachets, applied transdermally once daily for 6 weeks.
Followed by OL OTG for 8 weeks. Receives: Drug: Oxybutynin |
| OL: OTG (Post-Amend 3) | Experimental | Open-Label Oxybutynin Chloride topical gel (OTG) (Pre \& Post-Amendment 3) Oxybutynin Chloride topical gel (OTG), 0.5 g, 0.75 g (starting dose for Pre- and Post-Amendment 3), or 1 g sachets, applied transdermally once daily for 14 weeks. Receives: Drug: Oxybutynin |
| DB: Placebo (Pre-Amend 3) | Placebo comparator | Double-Blind Placebo (Pre-Amendment 3) Placebo Gel sachets applied transdermally once daily for 6 weeks. Followed by OL OTG for 8 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Percent of Catheterizations Without a Leaking Accident at Week 6
The primary efficacy endpoint is the change from baseline to Week 6 of treatment or the last observation carried forward in percentage of catheterizations without a leaking accident as recorded in a 2-day urinary diary.
Measured: Baseline (Week 0) up to Week 6
Secondary outcomes (3)
Change From Baseline in Average Volume of Urine Collected Per Catheterization at Week 6
Pre-Amendment 3:
Change from Baseline in Average Volume of Urine Collected per Catheterization at week 6 (calculated from the 2-day urinary diary data).
Measured: Baseline (Week 0) up to week 6
Change From Baseline in Average Volume of Urine Collected Per First (Morning Awakening) Catheterization at Week 6
Change from Baseline in Average Volume of Urine Collected Per First (Morning Awakening) Catheterization at week 6 (calculated from the 2-day urinary diary data).
Measured: Baseline (Week 0) up to Week 6
Change From Baseline in Average Number of Catheterizations Per Day at Week 6
Change from Baseline in Average Number of Catheterizations Per Day at Week 6 (calculated from the 2-day urinary diary data).
Measured: Baseline (Week 0) up to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study start17 May 2011
- Primary completion29 Aug 2023
- Study completion24 Oct 2023
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 Overactive DetrusorStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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
- Sequential
- Model description
- This study was initiated as a double-blind, placebo-controlled study with an open-label extension and was amended (in Protocol Amendment 3) to continue to enroll subjects under only open-label treatment.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192568
- Sponsor's protocol ID
- OG09002
- Status last verified
- Aug 2024
- First submitted
- 30 Aug 2010
- Last updated
- 4 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-part, Multicenter, Dose-titration Study Evaluating the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of Oxybutynin Chloride 10% Gel for the Treatment of Detrusor Overactivity Associated With a Neurological Condition in Pediatric Patients
- ClinicalTrials.gov ID
- NCT01192568
- Acronym / sponsor ID
- OG09002
- Conditions
- Overactive Detrusor, Neurogenic Bladder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 17 May 2011 (actual)
- Primary completion
- 29 Aug 2023 (actual)
- Study completion
- 24 Oct 2023 (actual)
- First posted
- 1 Sep 2010 (estimated)
- Results
- Posted 4 Sep 2024
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 safety and efficacy of Oxybutynin Chloride 10% Topical Gel in children 3 to less than 17 years old, who have overactive bladder due to a neurogenic condition. Children will be treated with 0.75 g of gel/day for two weeks. Patients will then return to the clinic for a potential dose titration. At this time their dose may be adjusted up to 1g/day, down to 0.5g/day, or remain the same at 0.75g of gel/day depending on the individual response and tolerability. The total treatment time is 14 weeks and total time on the study is 16 weeks.
Detailed description
This study will use a two-part, multicenter, dose-titration study in pediatric patients with a detrusor overactivity associated with a neurological condition
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This study was initiated as a double-blind, placebo-controlled study with an open-label extension and was amended (in Protocol Amendment 3) to continue to enroll subjects under only open-label treatment.
| Arm | Type | Receives |
|---|---|---|
| DB: OTG (Pre-Amend 3) | Experimental | Drug: OxybutyninDouble-Blind Oxybutynin Chloride topical gel (OTG) (Pre-Amendment 3) Oxybutynin Chloride topical gel (OTG), 0.5 g, 0.75 g (starting dose), or 1 g sachets, applied transdermally once daily for 6 weeks. Followed by OL OTG for 8 weeks. |
| OL: OTG (Post-Amend 3) | Experimental | Drug: OxybutyninOpen-Label Oxybutynin Chloride topical gel (OTG) (Pre \& Post-Amendment 3) Oxybutynin Chloride topical gel (OTG), 0.5 g, 0.75 g (starting dose for Pre- and Post-Amendment 3), or 1 g sachets, applied transdermally once daily for 14 weeks. |
| DB: Placebo (Pre-Amend 3) | Placebo comparator | Drug: PlaceboDouble-Blind Placebo (Pre-Amendment 3) Placebo Gel sachets applied transdermally once daily for 6 weeks. Followed by OL OTG for 8 weeks. |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 3 years to < 17 years
- Neurogenic bladder
- Neurological condition
- CIC
Key exclusion criteria (3 listed)
- Have anatomical bladder abnormalities
- Sensitivity to anticholinergics
- Bladder augmentation
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: Gelnique10% Oxybutynin Chloride Topical Gel, 0.5 g, 0.75 g, and 1 g/day, administered transdermally. | Drug | DB: OTG (Pre-Amend 3), OL: OTG (Post-Amend 3) |
| PlaceboTopical gel | Drug | DB: Placebo (Pre-Amend 3) |
Primary outcome
Change From Baseline in Percent of Catheterizations Without a Leaking Accident at Week 6
Time frame: Baseline (Week 0) up to Week 6
The primary efficacy endpoint is the change from baseline to Week 6 of treatment or the last observation carried forward in percentage of catheterizations without a leaking accident as recorded in a 2-day urinary diary.
3 secondary outcomes
Change From Baseline in Average Volume of Urine Collected Per Catheterization at Week 6
Time frame: Baseline (Week 0) up to week 6
Change From Baseline in Average Volume of Urine Collected Per First (Morning Awakening) Catheterization at Week 6
Time frame: Baseline (Week 0) up to Week 6
Change From Baseline in Average Number of Catheterizations Per Day at Week 6
Time frame: Baseline (Week 0) up to Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: 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.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Related trials for Overactive Detrusor
Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Not yet recruitingObservational study
Long-Term Effectiveness and Safety of Sacral Neuromodulation With InterStim for Lower Urinary Tract Dysfunction
Overactive Bladder (OAB), Urgency Urinary Incontinence
Recruiting
The Effectiveness of Transcutaneous Sacral Neuromodulation Techniques-Magnetic Stimulation and Electrical Stimulation-on Detrusor Overactivity in Patients With Spinal Cord Injury
Spinal Cord Injuries (SCI), Detrusor Overactivity
Active, not recruiting
Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder
Overactive Bladder, Overactive Bladder Syndrome
Recruiting
Effects of Sacral and Tibial Stimulation on Bladder Function in Subacute Suprasacral Spinal Cord Injury
Spinal Cord Injury, Detrusor Overacitivity
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.
ABBVIE INC. study director
AbbVie
10 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 Overactive Detrusor and Neurogenic Bladder, run by AbbVie at 10 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 4 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 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 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 4 Sep 2024). 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 Percent of Catheterizations Without a Leaking Accident at Week 6 (time frame: Baseline (Week 0) up to Week 6). 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 NCT01192568, 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 4 Sep 2024; AzTrials last refreshed its copy on 8 Nov 2026.