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Xylitol for Otitis Media

NCT02950311 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2017-12-22

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled study of children, age 6 months to 3 years, with a diagnosis of Otis media with effusion (OME) based on examination by a provider at a Duke- affiliated otolaryngology clinic.

Conditions

  • Otitis Media With Effusion

Interventions

DRUG

Intranasal xylitol spray

Two sprays into each nostril of intranasal xylitol spray will be administered to pediatric patients by parent(s)/caregiver(s) twice daily for 24 weeks.

OTHER

Intranasal saline spray

Two sprays into each nostril of intranasal xylitol spray will be administered to pediatric patients by parent(s)/caregiver(s) twice daily for 24 weeks.

Sponsors & Collaborators

Principal Investigators

  • Marissa Ryan, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-20
Primary Completion
2017-11-20
Completion
2017-11-20
FDA Drug
Yes

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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 NCT02950311 on ClinicalTrials.gov