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

May 16, 2011 updated by: Pfizer

A Randomized, Multicenter, Comparative Study To Assess Tolerability Of A Single Oral 60 Mg/Kg Dose Of Zmax (Pediatric Concentration) Vs. Zmax (Adult Concentration) In Pediatric Patients With Acute Otitis Media

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Cordoba, Argentina
        • Pfizer Investigational Site
  • Chile
    • RM
      • Santiago, RM, Chile
        • Pfizer Investigational Site
    • Santiago
      • Independencia, Santiago, Chile
        • Pfizer Investigational Site
      • Providencia, Santiago, Chile
        • Pfizer Investigational Site
  • Costa Rica
      • San Jose, Costa Rica
        • Pfizer Investigational Site
  • Dominican Republic
    • DN
      • Santo Domingo, DN, Dominican Republic
        • Pfizer Investigational Site
  • Guatemala
      • Ciudad Guatemala, Guatemala
        • Pfizer Investigational Site
      • Guatemala, Guatemala
        • Pfizer Investigational Site
  • Panama
      • Ciudad de Panama, Panama
        • Pfizer Investigational Site
  • United States
    • Kentucky
      • Bardstown, Kentucky, United States
        • Pfizer Investigational Site
      • Springfield, Kentucky, United States
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

August 2, 2006

First Submitted That Met QC Criteria

August 2, 2006

First Posted (Estimate)

August 3, 2006

Study Record Updates

Last Update Posted (Estimate)

May 17, 2011

Last Update Submitted That Met QC Criteria

May 16, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0661170

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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