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Oxybutynin for Bladder Infection
Phase 4
Waitlist Available
Research Sponsored by University of Calgary
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 four hours after each of the three doses of study medication.
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
Pivotal Trial
Summary
The primary goal of this study is to determine if the addition of the bladder antispasmotic oxybutynin to standard antimicrobial therapy in the treatment of childhood cystitis will decrease the associated pain and discomfort. A randomized, double blind, placebo-controlled clinical trial design will be used. The second goal of this study will be to describe the nature and duration of symptoms associated with uncomplicated cystitis in the paediatric age group. Finally, adverse side effects associated with short term use of oxybutynin will be monitored.
Eligible Conditions
- Bladder Infection
- Urinary Tract Infection
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ four hours after each of the three doses of study medication.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~four hours after each of the three doses of study medication.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain/discomfort ratings obtained at 4 hours after each of the three doses of study medication.
Secondary study objectives
Measurements of pain/discomfort with each urination recorded during the first 24 hours.
Number of supplemental doses of acetominophen used during the first 24 hours of the study.
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: OxybutyninExperimental Treatment2 Interventions
Children aged 4 - 6 years: Oxybutynin 2.5 mg (2.5ml) po TID Children aged 7 - 16 years: Oxybutynin 5 mg (5ml) po TID
Group II: PlaceboPlacebo Group2 Interventions
Orasweet liquid placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxybutynin
FDA approved
Antibiotics
2017
Completed Phase 4
~5180
Find a Location
Who is running the clinical trial?
University of CalgaryLead Sponsor
809 Previous Clinical Trials
886,302 Total Patients Enrolled
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