Status:
COMPLETED
Zmax Pediatric Vs Adult Concentration For The Treatment Of Acute Otitis Media
Lead Sponsor:
Pfizer
Conditions:
Otitis Media
Eligibility:
All Genders
3-48 years
Phase:
PHASE3
Brief Summary
Assess tolerability of different dosing formulations (adult versus pediatric).
Eligibility Criteria
Inclusion
- Have clinical signs/symptoms of AOM in at least 1 ear
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00360100
Start Date
August 1 2006
End Date
December 1 2006
Last Update
May 17 2011
Active Locations (10)
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1
Pfizer Investigational Site
Bardstown, Kentucky, United States
2
Pfizer Investigational Site
Springfield, Kentucky, United States
3
Pfizer Investigational Site
Córdoba, Córdoba Province, Argentina
4
Pfizer Investigational Site
Santiago, RM, Chile