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Antimuscarinic Agent

Oxybutynin Gel for Pediatric Overactive Bladder

Phase 4
Waitlist Available
Research Sponsored by Allergan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 0) up to week 6
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial tests a skin-applied gel medicine for children with bladder issues caused by nerve problems. The gel helps relax the bladder muscles to reduce overactivity. Children will use the gel for a few months, with doses adjusted based on their response.

Who is the study for?
This trial is for children aged 3 to less than 17 with an overactive bladder due to a neurogenic condition. They must be able to perform clean intermittent catheterization (CIC). Children cannot participate if they have sensitivity to anticholinergics, bladder augmentation, or anatomical bladder abnormalities.
What is being tested?
The study tests Oxybutynin Chloride 10% Topical Gel's safety and effectiveness in managing overactive bladders in children with neurogenic conditions. Treatment starts at 0.75 g of gel per day for two weeks, with possible dose adjustments after that based on response and tolerability for a total of 14 weeks.
What are the potential side effects?
Potential side effects may include dry mouth, constipation, headache, dizziness, blurred vision, and difficulty urinating. These are common side effects associated with anticholinergic medications like Oxybutynin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 0) up to week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0) up to week 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in Percent of Catheterizations Without a Leaking Accident at Week 6
Secondary study objectives
Change From Baseline in Average Number of Catheterizations Per Day at Week 6
Change From Baseline in Average Volume of Urine Collected Per Catheterization at Week 6
Change From Baseline in Average Volume of Urine Collected Per First (Morning Awakening) Catheterization at Week 6

Side effects data

From 2008 Phase 4 trial • 57 Patients • NCT00224016
18%
Infection
18%
Headache
15%
Urinary tract infection
15%
Fever
13%
Pharyngitis
13%
Rash
13%
Vomiting
10%
Pain
10%
Constipation
8%
Pain abdominal
8%
Pruritis
8%
Rhinitis
8%
Diarrhea
8%
Pain back
5%
VP shunt malfunction
5%
Skin ulcer
3%
Gastritis
3%
Knee wound dehiscence
3%
Worsening dehydration
3%
Tethered cord
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oxybutynin TDS
Oral Oxybutynin

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: OL: OTG (Post-Amend 3)Experimental Treatment1 Intervention
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.
Group II: DB: OTG (Pre-Amend 3)Experimental Treatment1 Intervention
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.
Group III: DB: Placebo (Pre-Amend 3)Placebo Group1 Intervention
Double-Blind Placebo (Pre-Amendment 3) Placebo Gel sachets applied transdermally once daily for 6 weeks. Followed by OL OTG for 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxybutynin
2015
Completed Phase 4
~2750

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Overactive Bladder (OAB) include anticholinergic agents like Oxybutynin Chloride. These medications work by blocking acetylcholine from binding to muscarinic receptors in the bladder muscle, which helps to relax the bladder and reduce involuntary contractions. This mechanism is important for OAB patients as it helps to manage symptoms such as frequent urination, urgency, and incontinence, ultimately improving their daily functioning and quality of life.
Trospium chloride: an update on a quaternary anticholinergic for treatment of urge urinary incontinence.

Find a Location

Who is running the clinical trial?

AllerganLead Sponsor
781 Previous Clinical Trials
276,602 Total Patients Enrolled
AbbVieLead Sponsor
1,023 Previous Clinical Trials
520,237 Total Patients Enrolled
Anna ChanStudy DirectorAllergan Sales, LLC
12 Previous Clinical Trials
1,088 Total Patients Enrolled

Media Library

Oxybutynin (Antimuscarinic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT01192568 — Phase 4
Neurogenic Bladder Research Study Groups: DB: OTG (Pre-Amend 3), OL: OTG (Post-Amend 3), DB: Placebo (Pre-Amend 3)
Neurogenic Bladder Clinical Trial 2023: Oxybutynin Highlights & Side Effects. Trial Name: NCT01192568 — Phase 4
Oxybutynin (Antimuscarinic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01192568 — Phase 4
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