CLINICAL TRIALS PROFILE FOR RETAPAMULIN
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All Clinical Trials for RETAPAMULIN
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00539994 ↗ | Retapamulin Ointment in Healthy Adults Nasally Colonized With Staphylococcus Aureus | Completed | GlaxoSmithKline | Phase 2 | 2007-09-01 | This is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and efficacy of Retapamulin ointment, 1% applied twice daily for 3 or 5 days to the anterior nares of healthy adult subjects who are nasally colonized with S. aureus. Approximately 57 healthy subjects who are nasal carriers of S. aureus will be enrolled and stratified in a 2:1 ratio so that at least 38 persistent carriers and 19 intermittent carriers complete the study. Each eligible subject will participate in three screening visits, a treatment period, and two follow-up visits. Each subject's participation in the study will be approximately 6 to 10 weeks from screening to the last follow-up visit. Subjects will participate in up to three screening visits to determine S. aureus culture positivity and colonization status. |
| NCT00555061 ↗ | Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections. | Completed | GlaxoSmithKline | Phase 4 | 2007-09-01 | 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). |
| NCT00684177 ↗ | Retapamulin Versus Placebo in Secondarily-Infected Traumatic Lesions (SITL) | Completed | GlaxoSmithKline | Phase 3 | 2008-05-01 | The purpose of Study TOC110977 is to demonstrate clinical superiority of Retapamulin ointment, 1%, over placebo in patients with secondarily-infected traumatic lesions, which includes secondarily-infected lacerations, abrasions and sutured wounds. Subjects 2 months of age and older will be treated with topical retapamulin or placebo ointment twice daily for 5 days. The primary endpoint of this study is the clinical response at follow-up (Day 12-14; 7-9 days after the end of therapy) in the intent-to-treat clinical population. |
| NCT00852540 ↗ | Retapamulin Versus Linezolid in the Treatment of SITL and Impetigo Due to MRSA | Completed | GlaxoSmithKline | Phase 3 | 2009-04-01 | The purpose of this study is to provide further evidence of the clinical and bacteriological efficacy of retapamulin in the treatment of subjects with SITL or impetigo due to MRSA. Subjects aged 2 months and older will be treated with either topical retapamulin for 5 days or oral linezolid for 10 days. The primary endpoint is the clinical response at follow-up (7-9 days after the end of therapy) in subjects who have a MRSA infection at baseline. The primary population is the per-protocol MRSA population. It is anticipated that approximately 500 subjects may be enrolled in order to obtain approximately 105 subjects who have a baseline MRSA infection. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for RETAPAMULIN
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Clinical Trial Progress for RETAPAMULIN
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Clinical Trial Sponsors for RETAPAMULIN
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