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

Primary Purpose

Otitis Media

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Zmax
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Otitis Media

Eligibility Criteria

3 Months - 48 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
August 2, 2006
Last Updated
May 16, 2011
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00360100
Brief Title
Zmax Pediatric Vs Adult Concentration For The Treatment Of Acute Otitis Media
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zmax
Primary Outcome Measure Information:
Title
Treatment-related vomiting on Day 1, which is based directly on the collected observed or voluntarily reported vomiting.
Secondary Outcome Measure Information:
Title
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.
Title
Frequency of the number of days of treatment-related vomiting by treatment group for subjects in the All Treated population.
Title
Frequencies of occurrence, by day, of treatment-related vomiting.
Title
Investigator and Sponsor assessment of clinical response.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
48 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Bardstown
State/Province
Kentucky
Country
United States
Facility Name
Pfizer Investigational Site
City
Springfield
State/Province
Kentucky
Country
United States
Facility Name
Pfizer Investigational Site
City
Cordoba
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Santiago
State/Province
RM
Country
Chile
Facility Name
Pfizer Investigational Site
City
Independencia
State/Province
Santiago
Country
Chile
Facility Name
Pfizer Investigational Site
City
Providencia
State/Province
Santiago
Country
Chile
Facility Name
Pfizer Investigational Site
City
San Jose
Country
Costa Rica
Facility Name
Pfizer Investigational Site
City
Santo Domingo
State/Province
DN
Country
Dominican Republic
Facility Name
Pfizer Investigational Site
City
Ciudad Guatemala
Country
Guatemala
Facility Name
Pfizer Investigational Site
City
Guatemala
Country
Guatemala
Facility Name
Pfizer Investigational Site
City
Ciudad de Panama
Country
Panama

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661170&StudyName=Zmax+Pediatric+Vs+Adult+Concentration+For+The+Treatment+Of+Acute+Otitis+Media++
Description
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Learn more about this trial

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

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