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

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00796224

First received: November 18, 2008

Last updated: February 1, 2010

Last verified: February 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

November 18, 2008

Last Updated Date

February 1, 2010

Start Date ^ICMJE

December 2008

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

pharmacokinetic parameters AUC72, AUCinf, Cmax, Tmax and t1/2 [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00796224 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

adverse events monitoring [ Time Frame: 28 days ] [ Designated as safety issue: No ]
clinical response [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Acute Otitis Media

Intervention ^ICMJE

Drug: 60 mg/kg azithromycin ER
subjects taken 60 mg/kg azithromycin ER

Other Name: Zithromax
Drug: 30 mg/kg azithromycin IR
subjects taken 30 mg/kg azithromycin IR (Immediate Release)

Other Name: Zithromax

Study Arm (s)

Active Comparator: 1.
60 mg/kg azithromycin ER (Extended Release)arm

Intervention: Drug: 60 mg/kg azithromycin ER
Active Comparator: 2.
30 mg/kg azithromycin IR (Immediate Release) arm

Intervention: Drug: 30 mg/kg azithromycin IR

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2009

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

6 Months to 11 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Costa Rica

Administrative Information

NCT Number ^ICMJE

NCT00796224

Other Study ID Numbers ^ICMJE

A0661190

Has Data Monitoring Committee

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

February 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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