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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

Study Summary

This trial will study the safety and effectiveness of a gel form of the drug oxybutynin in children 3-17 years old with overactive bladder due to a neurological condition.

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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of catheterizations without a leaking accident.
Secondary outcome measures
Average number of catheterizations per day
Average volume of urine collected at first (morning awakening) catheterization
Average volume of urine collected per catheterization (for Pre-Amendment 3 population only)

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Oxybutynin ChlorideExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxybutynin
2015
Completed Phase 4
~2720

Find a Location

Who is running the clinical trial?

AllerganLead Sponsor
781 Previous Clinical Trials
276,550 Total Patients Enrolled
AbbVieLead Sponsor
954 Previous Clinical Trials
501,025 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
Overactive Bladder Research Study Groups: Oxybutynin Chloride
Overactive 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What clinical situations is Oxybutynin prescribed to treat?

"Oxybutynin is a common pharmaceutical used to manage urinary urge incontinence, as well as certain neurological conditions and detrusor hyperreflexia."

Answered by AI

What criteria must a patient meet to be eligible for this research trial?

"This study seeks 58 minors aged 3 to 16 who have a neurogenic bladder. Participants must meet the following criteria: age range of 3 to <17, neurological condition requiring CIC (clean intermittent catheterization)."

Answered by AI

Could you provide a rundown of other research projects involving Oxybutynin?

"Oxybutynin was initially studied in 2011 at Cedars-Sinai Medical Center-West Hollywood. Since then, 52 trials have concluded with a further 5 now recruiting patients primarily located in Milwaukee, Wisconsin."

Answered by AI

Is the enrollment process open to individuals aged 25 and above for this clinical trial?

"Based on the study's inclusion criteria, 3 year olds and adolescents up to 16 years old can be enrolled in this trial."

Answered by AI

How widely available is this research taking place in the state?

"The current sites enrolling patients for this trial are situated in 17 different cities, with notable spots being Milwaukee, Loma Linda and Los Angeles. For the comfort of participants it is highly recommended to join a site close by them so as to minimize travel requirements."

Answered by AI

Does Oxybutynin present any significant risk to users?

"Owing to the Phase 4 status, which confirms Oxybutynin's approval, our team at Power assign this medication a safety score of 3."

Answered by AI

What is the current enrollment cap for this trial?

"In order to initiate the trial, AbbVie is required to recruit 58 participants who fit its inclusion criteria. Enrollment will be managed at two sites: Children's Hospital Wisconsin - Milwaukee Campus /ID# 245783 in Milwaukee, Wisconsin and Loma Linda University Health in Loma Linda, California."

Answered by AI

Is this research recruiting participants presently?

"Affirmative. According to clinicaltrials.gov, this study is actively seeking volunteers for its trial which was first published on May 2nd 2011 and most recently amended on November 9th 2022. The research team needs 58 patients across 17 medical centres."

Answered by AI

Is this the inaugural instance of a trial like this one?

"Oxybutynin has been studied since 2011, when AbbVie first sponsored its initial trial. With the conclusion of this 58-patient study in 2011, Oxybutynin was granted Phase 4 drug approval and is now being tested across 102 cities throughout two countries via 5 different trials."

Answered by AI

Who else is applying?

What site did they apply to?
University of Mississippi Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

Hope it will help me to understand better treatment for my condition.
PatientReceived 1 prior treatment
~1 spots leftby Apr 2025