Retapamulin Ointment in Healthy Adults Nasally Colonized With Staphylococcus Aureus
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.
Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections.
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).
Retapamulin Versus Placebo in Secondarily-Infected Traumatic Lesions (SITL)
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.
Serving leading biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data.
The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free.
thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user.
Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
Alerts Available With Subscription
Alerts are available for users with active subscriptions.