Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections.

This study has been completed.

Study NCT00555061 Information provided by GlaxoSmithKline

First Received on November 6, 2007. Last Updated on April 8, 2010 History of Changes

Results First Received: August 10, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Pharmacokinetics Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Skin Diseases, Infectious Skin Abnormalities Dermatoses Impetigo
Intervention:	Drug: Retapamulin Ointment, 1%

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
Retapamulin Ointment, 1%	Retapamulin ointment, 1%, administered twice daily for 5 consecutive days

Participant Flow: Overall Study

	Retapamulin Ointment, 1%
STARTED	87 ^[1]
COMPLETED	78
NOT COMPLETED	9
Adverse Event	3
Protocol Violation	1
Lost to Follow-up	2
Withdrawal by Subject	2
Participant enrolled, but never treated	1

[1]	One participant did not receive study medication and was not included in the analysis population.

Baseline Characteristics

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Reporting Groups

	Description
Retapamulin Ointment, 1%	Retapamulin ointment, 1%, administered twice daily for 5 consecutive days

Baseline Measures

	Retapamulin Ointment, 1%
Number of Participants [units: participants]	86
Age ^[1] [units: months] Mean ± Standard Deviation	10.6 ± 6.89
Gender ^[1] [units: participants]
Female	32
Male	54
Race/Ethnicity, Customized ^[1] [units: participants]
African American/African Heritage	46
White/Caucasian	36
American Indian or Alaska Native	1
Central/South Asian	1
East Asian	1
Missing	1

[1]	One participant was enrolled, but was withdrawn prior to assessments and did not receive study medication; therefore, this participant was not included in the study population.

Outcome Measures

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1. Primary:

Number of Participants With Measurable Plasma Concentrations, by Age Group [ Time Frame: Days 3 to 4; 4 to 8 hours post-dose of the first dose of the day ]

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2. Secondary:

Number of Participants With Clinical Success at Follow-up, by Type of Skin Infection and by Age [ Time Frame: Follow-up, Days 12 to 16 ]

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3. Secondary:

Bacteriological Success Rate at Follow-up, by Baseline Pathogen [ Time Frame: Follow-up, Days 12 to 16 ]

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4. Secondary:

Number of Participants by Age With Therapeutic Response of Success [ Time Frame: Follow-up, Days 12 to 16 ]

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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: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00555061 History of Changes
Other Study ID Numbers:	TOC106489
Study First Received:	November 6, 2007
Results First Received:	August 10, 2009
Last Updated:	April 8, 2010
Health Authority:	United States: Food and Drug Administration