Zmax Pediatric Vs Adult Concentration For The Treatment Of Acute Otitis Media
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
1 other identifier
interventional
120
7 countries
10
Brief Summary
Assess tolerability of different dosing formulations (adult versus pediatric).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2006
Shorter than P25 for phase_3
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 2, 2006
CompletedFirst Posted
Study publicly available on registry
August 3, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedMay 17, 2011
May 1, 2011
August 2, 2006
May 16, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment-related vomiting on Day 1, which is based directly on the collected observed or voluntarily reported vomiting.
Secondary Outcomes (4)
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.
Interventions
Eligibility Criteria
You may qualify if:
- Have clinical signs/symptoms of AOM in at least 1 ear
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (10)
Pfizer Investigational Site
Bardstown, Kentucky, United States
Pfizer Investigational Site
Springfield, Kentucky, United States
Pfizer Investigational Site
Córdoba, Córdoba Province, Argentina
Pfizer Investigational Site
Santiago, RM, Chile
Pfizer Investigational Site
Independencia, Santiago Metropolitan, Chile
Pfizer Investigational Site
Providencia, Santiago Metropolitan, Chile
Pfizer Investigational Site
San José, Costa Rica
Pfizer Investigational Site
Santo Domingo, DN, Dominican Republic
Pfizer Investigational Site
Guatemala City, Guatemala
Pfizer Investigational Site
Panama City, Panama
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 2, 2006
First Posted
August 3, 2006
Study Start
August 1, 2006
Study Completion
December 1, 2006
Last Updated
May 17, 2011
Record last verified: 2011-05