Pharmacokinetics Of Azithromycin Immediate Release And Extended Release Formulation In Kids With Acute Otitis Media - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00796224

Purpose

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 or 60 mg/kg ER formulation in pediatric subjects 6 months to 6 years of age inclusive.

Condition	Intervention	Phase
Acute Otitis Media	Drug: 60 mg/kg azithromycin ER Drug: 30 mg/kg azithromycin IR	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study
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

Resource links provided by NLM:

MedlinePlus related topics: Ear Infections

Drug Information available for: Azithromycin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Area Under the Curve From Time Zero to 72 Hours (AUC72Hours) [ Time Frame: Predose/0 to 72 Hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf) [ Time Frame: Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose ] [ Designated as safety issue: No ]
Maximum Observed Plasma Concentration (Cmax) of Azithromycin [ Time Frame: Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose ] [ Designated as safety issue: No ]
Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half Life (t1/2) of Azithromycin [ Time Frame: Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose ] [ Designated as safety issue: No ]
Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference) [ Time Frame: 1,2,3,4,8,24,48,72 hours postdose ] [ Designated as safety issue: No ]
Number of Participants With a Clinical Response [ Time Frame: Days 7,8,9 or 10 ] [ Designated as safety issue: No ]
Adverse Events (AEs) and Serious AEs (SAEs) [ Time Frame: Baseline up to 28 days ] [ Designated as safety issue: Yes ]

Enrollment:	38
Study Start Date:	December 2008
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 60 mg/kg azithromycin ER arm	Drug: 60 mg/kg azithromycin ER subjects taken 60 mg/kg azithromycin ER
2: Active Comparator 30 mg/kg azithromycin IR arm	Drug: 30 mg/kg azithromycin IR subjects taken 30 mg/kg azithromycin IR

Eligibility

Ages Eligible for Study:	6 Months to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects age 6 months to 6 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00796224

Locations

Costa Rica
Pfizer Investigational Site
San Jose, Costa Rica, 0000
Pfizer Investigational Site
San Jose, Costa Rica

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0661190
Study First Received:	November 18, 2008
Results First Received:	December 15, 2009
Last Updated:	January 27, 2010
ClinicalTrials.gov Identifier:	NCT00796224 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

azithromycin, pharmacokinetics, pediatrics

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Otorhinolaryngologic Diseases
Therapeutic Uses
Azithromycin

Otitis
Otitis Media
Ear Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010