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Oxybutynin Gel for Pediatric Overactive Bladder
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.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2008 Phase 4 trial • 57 Patients • NCT00224016Trial Design
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- You must be between 3 and 16 years old.You have a bladder issue related to nerve problems.You have a neurological condition.You have physical abnormalities in your bladder.You have had surgery to enlarge your bladder.You are sensitive to anticholinergic medications.It seems like the criterion "CIC" is not clear. It would be helpful to have more context or information to provide an accurate summary.
- Group 1: Oxybutynin Chloride
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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)."
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."
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."
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."
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."
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."
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."
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."
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