CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 326 enrolled
Drug / intervention
Xylitol syrup +1 moredrug
Likely dose
Xylitol syrup 7.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01044030
NCT01044030Phase 3Completed
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Xylitol Syrup for the Prevention of Acute Otitis Media in Otitis-prone Children

Boston Children's Hospital·interventional·Posted Jan 7, 2010·Updated Jun 20, 2018

In Brief

A Phase 3 clinical trial evaluating Xylitol syrup and Placebo for Acute Otitis Media. Completed, enrolled 326 participants across 2 sites.

Detailed Summary

The primary objective of the proposed study is to determine the effectiveness and safety of orally administered viscous-adherent xylitol syrup given in a dose of five grams three times daily for 12 weeks in reducing the incidence of clinically-diagnosed acute otitis media (ear infection) in children with a history of recurrent acute otitis media.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Otitis Media
CountriesUnited States
CollaboratorsNational Institute on Deafness and Other Communication Disorders (NIDCD)

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 7, 2010
Enrollment StartFeb 1, 2010
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 16.5 years ago

Interventions

Xylitol syrupdrug

7.5 mL (5 grams) by mouth three times daily

Placebodrug

7.5 mL by mouth three times daily