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Efficacy of Oxybutynin in Paediatric Cystitis

NCT03877289 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2022-12-12

No results posted yet for this study

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.

Conditions

  • Cystitis

Interventions

DRUG

Oxybutynin

Oxybutynin is a tertiary amine anticholinergic. It exerts both antispasmodic and antimuscarinic activity on smooth muscle. It also exerts analgesic and local anaesthetic effects.

OTHER

"Orasweet" Liquid Placebo

A formulated Oxybutynin placebo that is nearly identical in appearance, volume, weight, taste, and smell.

DRUG

Antibiotics

All patients in treatment and control arms were treated as a co-intervention with an oral antibioitic, the type of which was chosen by the child's attending physician. Possible prescribed antibiotics include: trimethoprim and sulfamethoxazole (Septra), Cefalotin, Cephalexin, Cefapirin, Cefdroxil, Cefazolin, Cefradine, Cefacetrile, Cefaloridine, Cefroxadine, Cefatrizine, Cefuroxime, Cefixime, amoxicillin/clavulanic acid (Clavulin), and Nitrofurantoin.

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03877289 on ClinicalTrials.gov