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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 6, 2007 | ||||
| Last Updated Date | May 15, 2009 | ||||
| Start Date ICMJE | September 2007 | ||||
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Plasma concentrations of retapamulin at anytime during the window of 4 to 8 hours post-dose of the first dose on Visit 2 (day 3 or day 4) overall and by age groups (=2 to =6 months, >6 to =12 months, and >12 to =24 months). | ||||
| Original Primary Outcome Measures ICMJE |
Plasma concentrations of retapamulin at anytime during the window of 4 to 8 hours post-dose of the first dose on Visit 2 (day 3 or day 4) overall and by age groups (=2 to =6 months, >6 to =12 months, and >12 to =24 months). [ Time Frame: 5 Days ] | ||||
| Change History | Complete list of historical versions of study NCT00555061 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Collection of safety data (adverse events and abnormal laboratory values). Clinical response at Follow-up (Day 12-16; 7-11 days after end of treatment). Bacteriological response at Follow-up. Therapeutic response at Follow-up. [ Time Frame: 5 Days ] | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections. | ||||
| Official Title ICMJE | An Open-Label, Non-Comparative Study to Assess the Pharmacokinetics, Safety and Efficacy of Topical Retapamulin (SB-275833) Ointment, 1%, Twice Daily for Five Days in the Treatment of Uncomplicated Skin and Skin Structure Infections in Pediatric Subjects Aged 2 to 24 Months | ||||
| Brief Summary | A study to evaluate the pharmacokinetics of Retapamulin Ointment, 1%, in pediatric subjects (2-24 months) with secondarily-infected traumatic lesions, secondarily-infected dermatoses, or impetigo (bullous and non-bullous). |
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| Detailed Description | |||||
| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Retapamulin Ointment, 1% | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Completion Date | August 2008 | ||||
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion criteria:
The subject has a small laceration, sutured wound or abrasion, which has a secondary bacterial infection. The infected portion of the laceration or sutured wound should not exceed 10cm in length with surrounding erythema not extending more than 2cm from the edge of the wound. Abrasions should not exceed 2% of the total body surface area with surrounding erythema not extending more than 2cm from the edge of the abrasion. The subject has a diagnosis of inflammatory skin disease (i.e., dermatosis), such as atopic dermatitis or contact dermatitis, which has a secondary bacterial infection. The infected portion of the lesion(s) should not exceed 2% of the total body surface area. Impetigo: The subject has a lesion or group of £10 discrete localized lesions on otherwise healthy skin, characterized by red spots or blisters without crusts which later progress to lesions which ooze and form yellow or honey-colored crusts surrounded by an erythematous margin.
Exclusion criteria:
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| Gender | Both | ||||
| Ages | 2 Months to 24 Months | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Argentina, Chile, Costa Rica, Germany, Mexico, Netherlands, South Africa | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00555061 | ||||
| Responsible Party | Study Director, GSK | ||||
| Study ID Numbers ICMJE | TOC106489 | ||||
| Study Sponsor ICMJE | GlaxoSmithKline | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | GlaxoSmithKline | ||||
| Verification Date | May 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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