Topical SB-275833 Ointment, 1% For The Treatment Of Impetigo

NCT00133874 | Completed Phase 3

• 1 other identifier: TOC100224
• Study Type: interventional
• Target: 520
• Locations: 10 countries
• Sites: 69

Brief Summary

The goal of this study is to determine if topical SB-275833 ointment, 1% is as safe and effective as topical sodium fusidate ointment, 2% for the treatment of impetigo in adults and children as young as 9 months of age.

Conditions

Skin Infections, Bacterial

Keywords

topical antibacterial; topical antibiotic; impetigo

Outcome Measures

Primary Outcomes (1)

• Clinical response assessed at end of therapy visit. Clinical success defined by the need for no additional antibiotic treatment.

  7 Days

Secondary Outcomes (1)

• Clinical response assessed at follow up visit. Microbiologic response at end of therapy and follow up visits. Impetigo lesion area measured at end of therapy and follow up visits.

  7 Days

Interventions

SB-275833 ointment, 1% DRUG

Also known as: SB-275833 ointment, 1%

Eligibility Criteria

• Age: 9 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have primary impetigo with total lesion area being 100 square centimeters or less.
• Women who could bear children must have a negative urine pregnancy test and agree to either abstain from sexual intercourse or the use of specific effective contraceptive measures.

You may not qualify if:

• Any signs and symptoms of systemic infection.
• Any serious underlying disease that could be imminently life threatening.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (69)

GSK Investigational Site

Winnipeg, Manitoba, R3A 1M3, Canada

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Winnipeg, Manitoba, R3C 0N2, Canada

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St. John's, Newfoundland and Labrador, A1E 2C2, Canada

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Brampton, Ontario, L6T 3J1, Canada

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Greater Sudbury, Ontario, P3E 6B4, Canada

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Kitchener, Ontario, N2C 2N9, Canada

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Toronto, Ontario, M9W 4L6, Canada

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San José, Costa Rica

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Anzin, 59410, France

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Bersée, 59235, France

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Labarth-Sur-Leze, 31860, France

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Martigues, 13500, France

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Paris, 75020, France

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Seraincourt, 95450, France

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Vieux-Condé, 59690, France

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Augsburg, Bavaria, 86179, Germany

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Gilching, Bavaria, 82205, Germany

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Munich, Bavaria, 80801, Germany

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Munich, Bavaria, 81241, Germany

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Mahlow, Brandenburg, 15831, Germany

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Duelmen, Lower Saxony, 48249, Germany

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Bad Honnef, North Rhine-Westphalia, 53604, Germany

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Bonn, North Rhine-Westphalia, 53177, Germany

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Cologne, North Rhine-Westphalia, 50674, Germany

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Düsseldorf, North Rhine-Westphalia, 40472, Germany

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Gelsenkirchen, North Rhine-Westphalia, 45879, Germany

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Kleve-Materborn, North Rhine-Westphalia, 47533, Germany

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Krefeld, North Rhine-Westphalia, 47798, Germany

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Mülheim, North Rhine-Westphalia, 45468, Germany

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Olpe, North Rhine-Westphalia, 57462, Germany

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Unna, North Rhine-Westphalia, 59423, Germany

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Wuppertal, North Rhine-Westphalia, 42103, Germany

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Worms, Rhineland-Palatinate, 67547, Germany

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Döbeln, Saxony, 04720, Germany

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Dresden, Saxony, 01097, Germany

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Reichenbach, Saxony, 08468, Germany

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Schmiedeberg, Saxony, 01762, Germany

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Kiel, Schleswig-Holstein, 24103, Germany

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Kiel, Schleswig-Holstein, 24148, Germany

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Preetz, Schleswig-Holstein, 24211, Germany

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Rendsburg, Schleswig-Holstein, 24768, Germany

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Berlin, State of Berlin, 10435, Germany

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Bangalore, 560002, India

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Bangalore, 560034, India

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Mumbai, 400 008, India

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Zapopan, Jalisco, Jalisco, 45190, Mexico

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Mexico City, 06780, Mexico

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Ermelo, 3851 EX, Netherlands

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GSK Investigational Site

Huizen, 1271 BB, Netherlands

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Losser, 7581 BV, Netherlands

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Musselkanaal, 9581 AJ, Netherlands

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GSK Investigational Site

Oude Pekela, 9665 AR, Netherlands

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Sittard, 6131 BK, Netherlands

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Soerendonk, 6027 RN, Netherlands

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Zieuwent, 7136 KH, Netherlands

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GSK Investigational Site

Zwijndrecht, 3331 LZ, Netherlands

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Breña, Lima 5, Peru

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Grudziądz, 86-300, Poland

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Katowice, 40-027, Poland

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Poznan, 60-355, Poland

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Wroclaw, 50-368, Poland

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Zabrze, 41-800, Poland

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Cape Town, 7460, South Africa

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Cape Town, 7925, South Africa

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Daveyton, 1520, South Africa

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Eloffsdal, Pretoria, 0084, South Africa

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Newtown, 2113, South Africa

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GSK Investigational Site

Pretoia, 0084, South Africa

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GSK Investigational Site

Pretoria, 0001, South Africa

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Cellulitis; Impetigo

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Staphylococcal Skin Infections; Staphylococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Skin Diseases, Bacterial; Skin Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2005
• First Posted: August 24, 2005
• Study Start: April 1, 2005
• Primary Completion: September 1, 2005
• Study Completion: September 1, 2005
• Last Updated: January 23, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

ME (2); ZA (7); NL (9); IN (3); CA (7); CO (1); PL (5); PE (1); DE (27); FR (7)