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

This study has been completed.

Study NCT00796224 Information provided by Pfizer

First Received on November 18, 2008. Last Updated on February 1, 2010 History of Changes

Results First Received: December 15, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacokinetics Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Acute Otitis Media
Interventions:	Drug: 60 mg/kg azithromycin ER Drug: 30 mg/kg azithromycin IR

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
60 mg/kg Azithromycin Extended-release (ER)	Subjects received 60 mg/kg Azithromycin ER single oral dose on Day 1.
30 mg/kg Azithromycin Immediate-release (IR)	Subjects received 30 mg/kg Azithromycin IR single oral dose on Day 1.

Participant Flow: Overall Study

	60 mg/kg Azithromycin Extended-release (ER)	30 mg/kg Azithromycin Immediate-release (IR)
STARTED	19	19
COMPLETED	18	18
NOT COMPLETED	1	1
Adverse Event	1	0
Protocol Violation	0	1

Baseline Characteristics

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Reporting Groups

	Description
60 mg/kg Azithromycin ER	Subjects received 60 mg/kg Azithromycin ER single oral dose on Day 1.
30 mg/kg Azithromycin IR	Subjects received 30 mg/kg Azithromycin IR single oral dose on Day 1.

Baseline Measures

	60 mg/kg Azithromycin ER	30 mg/kg Azithromycin IR	Total
Number of Participants [units: participants]	19	19	38
Age, Customized [units: participants]
1 month to <2 years	13	6	19
2 years to <12 years	6	13	19
Gender [units: participants]
Female	8	7	15
Male	11	12	23

Outcome Measures

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1. Primary:

Area Under the Curve From Time Zero to 72 Hours (AUC72Hours) [ Time Frame: Predose/0 to 72 Hours ]

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2. Secondary:

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 ]

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3. Secondary:

Maximum Observed Plasma Concentration (Cmax) of Azithromycin [ Time Frame: Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose ]

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4. Secondary:

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 ]

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5. Secondary:

Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference) [ Time Frame: 1,2,3,4,8,24,48,72 hours postdose ]

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6. Secondary:

Number of Participants With a Clinical Response [ Time Frame: Days 7,8,9 or 10 ]

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7. Secondary:

Adverse Events (AEs) and Serious AEs (SAEs) [ Time Frame: Baseline up to 28 days ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00796224 History of Changes
Other Study ID Numbers:	A0661190
Study First Received:	November 18, 2008
Results First Received:	December 15, 2009
Last Updated:	February 1, 2010
Health Authority:	United States: Food and Drug Administration