Zmax Pediatric Vs Adult Concentration For The Treatment Of Acute Otitis Media

Phase 3CompletedNCT00360100

Pfizer120 enrolled

Overview

Assess tolerability of different dosing formulations (adult versus pediatric).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Otitis Media

Interventions

ZmaxDRUG

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 48 Months

Medical Language ↔ Plain English

Inclusion Criteria: * Have clinical signs/symptoms of AOM in at least 1 ear Exclusion Criteria: * Known or suspected hypersensitivity, or intolerance to azithromycin or other macrolides or to any penicillin, beta-lactam antibiotic or beta lactamase inhibitor * Previously diagnosed disease(s) of immune function * Treatment with any systemic (intravenous, intramuscular, oral) antibiotic for any indication within 7 days prior to enrollment

Locations (10)

Pfizer Investigational Site

Bardstown, Kentucky, United States

Pfizer Investigational Site

Springfield, Kentucky, United States

Pfizer Investigational Site

Córdoba, Córdoba Province, Argentina

Outcomes

Primary Outcomes

Treatment-related vomiting on Day 1, which is based directly on the collected observed or voluntarily reported vomiting.

Secondary Outcomes

Time-to-vomiting (in minutes) will be measured for all vomiting episodes that occur within the 60-minute observation period post-dosing on Day 1.

Frequency of the number of days of treatment-related vomiting by treatment group for subjects in the All Treated population.

Frequencies of occurrence, by day, of treatment-related vomiting.

Investigator and Sponsor assessment of clinical response.

Data from ClinicalTrials.gov

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