MedTrace Logo

A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media

NCT00644943 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 425

Last updated 2008-03-27

No results posted yet for this study

Summary

The primary objective is to compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg/day ql2hrs for 5 days, to amoxicillin/clavulanate oral suspension 45 mg/kg/day (based on amoxicillin component), in divided doses, q12h for 10 days, in children between 6 months and 6 years of age, with AOM.

Conditions

  • Acute Otitis Media

Interventions

DRUG

cefdinir (Omnicef)

oral suspension (7 mg/kg, ql2hr) for 5 days

DRUG

amoxicillin

oral suspension (45 mg/kg/day, q l2 hours) for 10 days

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE

Eligibility

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

Timeline & Regulatory

Start
2003-02-28
Primary Completion
2003-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT00644943 on ClinicalTrials.gov