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NCT00796224 Clinical Trial

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

Acute Otitis Media Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00796224
Other study ID # A0661190
Secondary ID
Status Completed
Phase Phase 2
First received November 18, 2008
Last updated February 1, 2010
Start date December 2008
Est. completion date February 2009

Study information
Verified date February 2010
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date February 2009
Est. primary completion date February 2009
Accepts healthy volunteers No
Gender Both
Age group 6 Months to 11 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• 60 mg/kg azithromycin ER
subjects taken 60 mg/kg azithromycin ER
• 30 mg/kg azithromycin IR
subjects taken 30 mg/kg azithromycin IR (Immediate Release)

Locations
Country Name City State
Costa Rica Pfizer Investigational Site San Jose
Costa Rica Pfizer Investigational Site San Jose

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Costa Rica, 

Outcome
Type Measure Description Time frame Safety issue
Primary Area Under the Curve From Time Zero to 72 Hours (AUC72Hours) Predose/0 to 72 Hours No
Secondary 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 No
Secondary Maximum Observed Plasma Concentration (Cmax) of Azithromycin Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose No
Secondary 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 No
Secondary Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference) 1,2,3,4,8,24,48,72 hours postdose No
Secondary Number of Participants With a Clinical Response Days 7,8,9 or 10 No
Secondary Adverse Events (AEs) and Serious AEs (SAEs) Baseline up to 28 days Yes
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