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

NCT ID: NCT00360100

Last Updated: 2011-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2006-12-31

Brief Summary

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

Detailed Description

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Conditions

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Otitis Media

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Zmax

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

3 Months

Maximum Eligible Age

48 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Bardstown, Kentucky, United States

Site Status

Pfizer Investigational Site

Springfield, Kentucky, United States

Site Status

Pfizer Investigational Site

Córdoba, Córdoba Province, Argentina

Site Status

Pfizer Investigational Site

Santiago, RM, Chile

Site Status

Pfizer Investigational Site

Independencia, Santiago Metropolitan, Chile

Site Status

Pfizer Investigational Site

Providencia, Santiago Metropolitan, Chile

Site Status

Pfizer Investigational Site

San José, , Costa Rica

Site Status

Pfizer Investigational Site

Santo Domingo, DN, Dominican Republic

Site Status

Pfizer Investigational Site

Guatemala City, , Guatemala

Site Status

Pfizer Investigational Site

Panama City, , Panama

Site Status

Countries

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United States Argentina Chile Costa Rica Dominican Republic Guatemala Panama

Related Links

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Other Identifiers

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A0661170

Identifier Type: -

Identifier Source: org_study_id

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