A Open Label, Randomized, Single Dose, Parallel Arm Study To Determine Pharmacokinetics Of Azithromycin Following Oral Administration Of Immediate-Release Or Extended-Release Formulation In Pediatric Subjects With Acute Otitis Media

Pfizer1 site in 1 country38 target enrollmentDecember 2008

ConditionsAcute Otitis Media

Interventions60 mg/kg azithromycin ER 30 mg/kg azithromycin IR

Drugs60 mg/kg azithromycin ER 30 mg/kg azithromycin IR

Overview

Phase: Phase 2
Intervention: 60 mg/kg azithromycin ER
Conditions: Acute Otitis Media
Sponsor: Pfizer
Enrollment: 38
Locations: 1
Primary Endpoint: Area Under the Curve From Time Zero to 72 Hours (AUC72Hours)
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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) formulation in pediatric subjects 6 months to 6 years of age inclusive.

Registry

clinicaltrials.gov

Start Date

December 2008

End Date

February 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•Clinical significant other disease.
•Recent use of investigational drugs, prescription or nonprescription drugs.

Arms & Interventions

1.

60 mg/kg azithromycin ER (Extended Release)arm

Intervention: 60 mg/kg azithromycin ER

2.

30 mg/kg azithromycin IR (Immediate Release) arm

Intervention: 30 mg/kg azithromycin IR

Outcomes

Primary Outcomes

Area Under the Curve From Time Zero to 72 Hours (AUC72Hours)

Time Frame: Predose/0 to 72 Hours

AUC72 = Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours.

Secondary Outcomes

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf)(Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose)
Maximum Observed Plasma Concentration (Cmax) of Azithromycin(Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose)
Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half Life (t1/2) of Azithromycin(Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose)
Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference)(1,2,3,4,8,24,48,72 hours postdose)
Number of Participants With a Clinical Response(Days 7,8,9 or 10)
Adverse Events (AEs) and Serious AEs (SAEs)(Baseline up to 28 days)