Retapamulin Versus Placebo in Secondarily-Infected Traumatic Lesions (SITL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00684177
First received: May 22, 2008
Last updated: August 23, 2012
Last verified: August 2012
Results First Received: June 3, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Secondarily-infected Abrasions
Secondarily-infected Lacerations
Secondarily-infected Sutured Wounds
Secondarily-infected Traumatic Lesions
Skin Infections, Bacterial
Interventions: Drug: Retapamulin Ointment, 1%
Drug: Placebo ointment

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 508 participants were randomized. One participant did not receive treatment; thus, no data were collected for this participant. Only 507 participants were included in the analysis.

Reporting Groups
  Description
Retapamulin Topical retapamulin ointment, 1% twice daily for 5 days
Placebo Matching placebo

Participant Flow:   Overall Study
    Retapamulin     Placebo  
STARTED     343     164  
COMPLETED     322     141  
NOT COMPLETED     21     23  
Adverse Event                 4                 3  
Lack of Efficacy                 10                 15  
Protocol Violation                 1                 0  
Lost to Follow-up                 2                 1  
Physician Decision                 2                 0  
Withdrawal by Subject                 1                 2  
Unknown                 1                 2  



  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 Topical retapamulin ointment, 1% twice daily for 5 days
Placebo Matching placebo
Total Total of all reporting groups

Baseline Measures
    Retapamulin     Placebo     Total  
Number of Participants  
[units: participants]
  343     164     507  
Age  
[units: years]
Mean ± Standard Deviation
  32.6  ± 18.77     28.6  ± 18.32     31.3  ± 18.70  
Gender  
[units: participants]
     
Female     144     63     207  
Male     199     101     300  
Race/Ethnicity, Customized  
[units: participants]
     
African American/African Heritage     144     71     215  
American Indian or Alaskan Native     9     3     12  
Asian - Central / South Asian Heritage     0     1     1  
Asian - East Asian Heritage     4     2     6  
Asian - South East Asian Heritage     33     15     48  
Native Hawaiian or Other Pacific Islander     1     2     3  
White - Arabic/North African Heritage     1     0     1  
White - White/Caucasian/European Heritage     132     61     193  
Mixed Race     19     9     28  



  Outcome Measures
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1.  Primary:   Number of Participants With Clinical Success and Failure at Follow-up (7-9 Days Post Therapy) for the Primary Efficacy Population   [ Time Frame: Days 12-14 ]

2.  Secondary:   Number of Participants With Clinical Success and Failure at Follow-up (7-9 Days Post Therapy) for the Intent-to-Treat Bacteriology (ITTB) Subset of the Primary Efficacy Population   [ Time Frame: Days 12-14 ]

3.  Secondary:   Number of Participants With Microbiological Success and Failure at Follow-up (7-9 Days Post Therapy)   [ Time Frame: Days 12-14 ]

4.  Secondary:   Number of Participants With the Indicated Clinical Outcome at End of Therapy (2-4 Days Post Therapy)   [ Time Frame: Days 7-9 ]

5.  Secondary:   Number of Baseline Pathogens With the Indicated Microbiological Outcome at End of Therapy (2-4 Days Post Therapy)   [ Time Frame: Days 7-9 ]

6.  Secondary:   Number of Participants With Therapeutic Success and Failure at Follow-up (7-9 Days Post Therapy)   [ Time Frame: Follow-up (Days 12-14) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00684177     History of Changes
Other Study ID Numbers: TOC110977
Study First Received: May 22, 2008
Results First Received: June 3, 2010
Last Updated: August 23, 2012
Health Authority: United States: Food and Drug Administration