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

Primary Purpose

Acute Otitis Media

Status

Completed

Phase

Phase 2

Locations

Costa Rica

Study Type

Interventional

Intervention

60 mg/kg azithromycin ER

30 mg/kg azithromycin IR

About this trial

This is an interventional treatment trial for Acute Otitis Media focused on measuring azithromycin, pharmacokinetics, pediatrics

Eligibility Criteria

6 Months - 11 Years (Child)All SexesDoes not accept 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.

Sites / Locations

Pfizer Investigational Site
Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

60 mg/kg azithromycin ER (Extended Release)arm

30 mg/kg azithromycin IR (Immediate Release) arm

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf)

AUCinf = AUClast + (Clast* divided by kel), where AUClast is calculated by Linear-Log trapezoidal method, Clast* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

Maximum Observed Plasma Concentration (Cmax) of Azithromycin

Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half Life (t1/2) of Azithromycin

Plasma decay half-life is the time measured for the plasma concentration to decrease by one-half.

Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference)

Number of Participants With a Clinical Response

Clinical response was assesed between Days 7 and 10, or when subjects discontinued the study prematurely (if applicable). Response was assessed by the investigator as cure or failure. Cure = Clinical signs and symptoms related to the acute illness have resolved, or clinical improvement is such that no additional therapy is necessary. Failure = One or more of the following: Signs and symptoms related to the acute illness have persisted or worsened and additional therapy is necessary; New clinical signs and symptoms of acute illness have developed and additional therapy is necessary

Adverse Events (AEs) and Serious AEs (SAEs)

All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) was reported.

Full Information

NCT ID

NCT00796224

First Posted

November 18, 2008

Last Updated

February 1, 2010

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00796224

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2010

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

February 2009 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Otitis Media

Keywords

azithromycin, pharmacokinetics, pediatrics

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

60 mg/kg azithromycin ER (Extended Release)arm

Arm Title

Arm Type

Active Comparator

Arm Description

30 mg/kg azithromycin IR (Immediate Release) arm

Intervention Type

Drug

Intervention Name(s)

60 mg/kg azithromycin ER

Other Intervention Name(s)

Zithromax

Intervention Description

subjects taken 60 mg/kg azithromycin ER

Intervention Type

Drug

Intervention Name(s)

30 mg/kg azithromycin IR

Other Intervention Name(s)

Zithromax

Intervention Description

subjects taken 30 mg/kg azithromycin IR (Immediate Release)

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Predose/0 to 72 Hours

Secondary Outcome Measure Information:

Title

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf)

Description

Time Frame

Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose

Title

Maximum Observed Plasma Concentration (Cmax) of Azithromycin

Time Frame

Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose

Title

Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half Life (t1/2) of Azithromycin

Description

Plasma decay half-life is the time measured for the plasma concentration to decrease by one-half.

Time Frame

Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose

Title

Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference)

Time Frame

1,2,3,4,8,24,48,72 hours postdose

Title

Number of Participants With a Clinical Response

Description

Time Frame

Days 7,8,9 or 10

Title

Adverse Events (AEs) and Serious AEs (SAEs)

Description

All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) was reported.

Time Frame

Baseline up to 28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

San Jose

ZIP/Postal Code

0000

Country

Costa Rica

Facility Name

Pfizer Investigational Site

City

San Jose

Country

Costa Rica

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661190&StudyName=Pharmacokinetics%20Of%20Azithromycin%20Immediate%20Release%20And%20Extended%20Release%20Formulation%20In%20Kids%20With%20Acute%20Otitis%20Media

Description

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

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