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NCT00360100 Clinical Trial

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

Otitis Media Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00360100
Other study ID # A0661170
Secondary ID
Status Completed
Phase Phase 3
First received August 2, 2006
Last updated May 16, 2011
Start date August 2006
Est. completion date December 2006

Study information
Verified date May 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 3 Months to 48 Months
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Zmax

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

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Chile,  Costa Rica,  Dominican Republic,  Guatemala,  Panama, 

Outcome
Type Measure Description Time frame Safety issue
Primary Treatment-related vomiting on Day 1, which is based directly on the collected observed or voluntarily reported vomiting.
Secondary 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.
Secondary Frequency of the number of days of treatment-related vomiting by treatment group for subjects in the All Treated population.
Secondary Frequencies of occurrence, by day, of treatment-related vomiting.
Secondary Investigator and Sponsor assessment of clinical response.
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