Status:
COMPLETED
Pharmacokinetics Of Azithromycin Immediate Release And Extended Release Formulation In Kids With Acute Otitis Media
Lead Sponsor:
Pfizer
Conditions:
Acute Otitis Media
Eligibility:
All Genders
6-11 years
Phase:
PHASE2
Brief Summary
The purpose of this study was to determine the pharmacokinetics (PK), safety and clinical response following a single dose of either 30 mg/kg IR (Immediate Release) or 60 mg/kg ER (Extended Release) f...
Eligibility Criteria
Inclusion
- Subjects age 6 months to \< 12 years.
- Have clinical signs/symptoms of acute otitis media in at least one ear.
- Parent(s)/legal guardian(s) provide written informed consent.
Exclusion
- Clinical significant other disease.
- Recent use of investigational drugs, prescription or nonprescription drugs.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00796224
Start Date
December 1 2008
End Date
February 1 2009
Last Update
February 18 2010
Active Locations (2)
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1
Pfizer Investigational Site
San José, Provincia de San José, Costa Rica, 0000
2
Pfizer Investigational Site
San José, Provincia de San José, Costa Rica