Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00555061
First received: November 6, 2007
Last updated: November 1, 2012
Last verified: October 2012
Results First Received: August 10, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Skin Infections, Bacterial
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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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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
  Show All Outcome Measures

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 ]

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 ]

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

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


  Serious Adverse Events


  Other Adverse Events


  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:
unchecked 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.
unchecked 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.


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: GlaxoSmithKline
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: November 1, 2012
Health Authority: United States: Food and Drug Administration