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

NCT ID: NCT00684177

Last Updated: 2016-11-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

508 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-10-31

Brief Summary

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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.

Detailed Description

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This is a prospective, multicenter, double-blind, placebo-controlled parallel group study in subjects aged 2 months and older with SITL, including secondarily-infected lacerations, sutured wounds or abrasions. A laceration or sutured wound cannot exceed 10 cm in length with surrounding erythema not extending more than 2 cm from the edge of the lesion. Abrasions cannot exceed 100 cm2 in total area, or up to a maximum of 2% total body surface area for subjects \<18 years of age, with surrounding erythema not extending more than 2 cm from the edge of the abrasion.

There are four study visits occurring over a 12-14 day period. At the Baseline visit (Visit 1, Day 1), subjects will be randomized to receive retapamulin or placebo ointment in a 2:1 (retapamulin:placebo) ratio. The 2:1 randomization is included to minimize the number of subjects exposed to treatment with placebo. Both active treatment and placebo will be dosed topically twice daily (BID) for 5 days. All subjects will receive a telephone call from the investigator or appropriate designee appointed by the investigator on Day 2. The subject will be interviewed to determine if there is any evidence of worsening infection. Subjects who are thought to be worsening will be instructed to come in to the clinic for an assessment. Subjects will be monitored and clinically evaluated at the On-therapy (Days 3-4), End of Therapy (Days 7-9), and Follow-up (Days 12-14) visits.

Randomization will be center-based and performed using an appropriate Interactive Voice Response System (IVRS), an automated telephone system. The block size will remain confidential.

Subjects are considered to have completed the study if they meet all inclusion/exclusion criteria, are considered compliant with study medication, and attend all study visits as defined by the protocol.

Conditions

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Skin Infections, Bacterial

Keywords

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infection retapamulin secondarily-infected traumatic lesions placebo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Retapamulin Ointment, 1%

Group Type EXPERIMENTAL

Retapamulin Ointment, 1%

Intervention Type DRUG

Provided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse taper puncture tip caps.

Placebo Ointment

Group Type PLACEBO_COMPARATOR

Placebo ointment

Intervention Type DRUG

Provided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse taper puncture tip caps.

Interventions

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Retapamulin Ointment, 1%

Provided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse taper puncture tip caps.

Intervention Type DRUG

Placebo ointment

Provided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse taper puncture tip caps.

Intervention Type DRUG

Other Intervention Names

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Retapamulin Ointment 1%

Eligibility Criteria

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Inclusion Criteria

* subject is aged 2 months or older
* subject has secondarily-infected traumatic lesion (laceration, sutured wound or abrasion)
* negative urine pregnancy test
* subject has total skin infection rating scale score of at least 8, including pus/exudate score of at least 3
* subject and/or parent/legal guardian is willing and able to comply with protocol
* subject or parent/legal guardian has given written informed consent or assent as applicable

Exclusion Criteria

* previous hypersensitivity to pleuromutilin
* secondarily-infected animal/human bite or puncture wound
* subject has an abscess
* chronic ulcerative lesion
* underlying skin disease
* systemic signs and symptoms of infection
* infection not appropriately treated with topical antibiotic
* infection requires surgical intervention prior to or during study
* subject received systemic antibacterial or steroid, or topical therapeutic agent within 24 hours of entry into study
* serious underlying disease
* subject pregnant, breast feeding or planning a pregnancy, or unacceptable method of contraception
* other investigational drug within 30 days of study entry
* subject previously enrolled in this study
Minimum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Tucson, Arizona, United States

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Anaheim, California, United States

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Fresno, California, United States

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Irvine, California, United States

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Los Angeles, California, United States

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Sacramento, California, United States

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Colorado Springs, Colorado, United States

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Deerfield Beach, Florida, United States

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Hollywood, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Panama City, Florida, United States

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Tampa, Florida, United States

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Vero Beach, Florida, United States

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West Palm Beach, Florida, United States

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Arlington Heights, Illinois, United States

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Kansas City, Kansas, United States

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New Orleans, Louisiana, United States

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Butte, Montana, United States

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Teaneck, New Jersey, United States

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Brooklyn, New York, United States

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Brooklyn, New York, United States

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East Syracuse, New York, United States

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Johnson City, New York, United States

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Cincinnati, Ohio, United States

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Norristown, Pennsylvania, United States

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Uniontown, Pennsylvania, United States

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Greenville, South Carolina, United States

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Houston, Texas, United States

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Bountiful, Utah, United States

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Vienna, Virginia, United States

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Buenos Aires, Buenos Aires, Argentina

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Chivilocoy, Buenos Aires, Argentina

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Loma Hermosa, Buenos Aires, Argentina

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Buenos Aires, , Argentina

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Curitiba, Paraná, Brazil

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Curitiba/Paraná, Paraná, Brazil

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Passo Fundo, Rio Grande do Sul, Brazil

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Bangalore, , India

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Lucknow, , India

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Pune, , India

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Vadodara, , India

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Wardha, , India

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Belville, , South Africa

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Benoni, , South Africa

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Cape Town, , South Africa

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Cape Town, , South Africa

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Hatfield, , South Africa

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Lynnwood, , South Africa

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Midrand, , South Africa

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Newton, , South Africa

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Welkom, , South Africa

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GSK Investigational Site

Worcester, , South Africa

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Countries

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Peru Philippines United States Argentina Brazil India South Africa

Study Documents

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Document Type: Annotated Case Report Form

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Study Protocol

View Document

Document Type: Clinical Study Report

View Document

Document Type: Informed Consent Form

View Document

Document Type: Dataset Specification

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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TOC110977

Identifier Type: -

Identifier Source: org_study_id