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NCT00555061 · ClinicalTrials.gov registry record · Phase 4

Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections.

A Phase 4 study of Skin Infections, Bacterial, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 4
Development phase
60
Enrollment target
20
Study locations

NCT00555061: Completed Phase 4 study of Skin Infections, Bacterial, sponsored by GlaxoSmithKline.

NCT00555061 is a Phase 4 study of Skin Infections, Bacterial that has completed, run by GlaxoSmithKline. The registered enrollment target is 60 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00555061, a Phase 4 study of Skin Infections, Bacterial, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 4
Development phase
60 participants
Enrollment target
20
Study locations

Study 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).

Primary Outcome

Pharmacokinetic (PK) samples were collected randomly in the window of 4 to 8 hours post-dose (except one at 3 hours and one at 11 hours post-dose) after the first daily dose of treatment on Day 3 or Day 4. The lower limit of quantification (LLQ) for retapamulin was 0.5 ng/mL.

Conditions Studied

Interventions

  • DRUG Retapamulin Ointment, 1%

Study Locations (20)

Other

  • GSK Investigational Site - San José
  • GSK Investigational Site - México
  • GSK Investigational Site - Alphen aan den Rijn
  • GSK Investigational Site - Losser
  • GSK Investigational Site - Roelofarendsveen
  • GSK Investigational Site - Rotterdam

North Rhine-Westphalia

  • GSK Investigational Site - Bochum
  • GSK Investigational Site - Erkrath
  • GSK Investigational Site - Goch
  • GSK Investigational Site - Kleve-Materborn

Buenos Aires

  • GSK Investigational Site - Ciudad Autonoma de Buenos Aires
  • GSK Investigational Site - Ciudad Autonoma de Buenos Aires

Alabama

  • GSK Investigational Site - Tuscaloosa

Arkansas

  • GSK Investigational Site - Bentonville

California

  • GSK Investigational Site - Orange

Massachusetts

  • GSK Investigational Site - Woburn

Ohio

  • GSK Investigational Site - Cleveland

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2007-09
Est. Completion 2008-08
Phase Phase 4
GlaxoSmithKline

1,345 total trials

What the finished NCT00555061 record still lists

NCT00555061 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).

The record links to 1 condition, with Skin Infections, Bacterial appearing as the primary indexed condition, and to 1 intervention - of which Retapamulin Ointment, 1% is the first listed.

NCT00555061 names 20 study sites across 11 states, led by Other, North Rhine-Westphalia, Buenos Aires.

Frequently Asked Questions

What is clinical trial NCT00555061 about?

NCT00555061 is a clinical study titled "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).

What is the current status of trial NCT00555061?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2007-09. Estimated completion is 2008-08.

What conditions does trial NCT00555061 study?

This clinical trial studies the following conditions: Skin Infections, Bacterial.

What interventions are being tested in trial NCT00555061?

The interventions under investigation include: Retapamulin Ointment, 1% (DRUG).

Who is sponsoring clinical trial NCT00555061?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00555061 being conducted?

This trial has 20 study locations across Alabama, Arkansas, California, Massachusetts, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Skin Infections, Bacterial

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00555061's enrollment target sits among peer trials

60 1125th of 2000 higher than 799 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00555061, the US trial registry maintained by the National Library of Medicine. NCT00555061 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.