Pharmacokinetics Of Azithromycin Immediate Release And Extended Release Formulation In Kids With Acute Otitis Media

Pfizer

Status and phase: Completed; Phase 2

Conditions: Acute Otitis Media

Treatments: Drug: 30 mg/kg azithromycin IR; Drug: 60 mg/kg azithromycin ER

Study type: Interventional

Funder types: Industry

Identifiers

NCT00796224

A0661190

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 6 months to 11 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

38 participants in 2 patient groups

1.

Active Comparator group

Description:

60 mg/kg azithromycin ER (Extended Release)arm

Treatment:

Drug: 60 mg/kg azithromycin ER

2.

Active Comparator group

Description:

30 mg/kg azithromycin IR (Immediate Release) arm

Treatment:

Drug: 30 mg/kg azithromycin IR