Last updated: 11/07/2018 19:38:23
Topical SB-275833 Ointment, 1% For The Treatment Of Impetigo
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An observer-blind, Multicenter, Non-inferiority, Comparative Study of the Safety and Efficacy of Topical 1% SB-275833 Ointment, Applied Twice Daily for 5 Days, versus Topical 2% Fusidic acid cream Applied Three Times daily for 7 days in the Treatment adult and paediatric subjects with Impetigo
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:
Clinical response assessed at end of therapy visit. Clinical success defined by the need for no additional antibiotic treatment.
Timeframe: 7 Days
Secondary outcomes:
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.
Timeframe: 7 Days
Interventions:
Drug: SB-275833 ointment, 1%
Enrollment:
520
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Arnold P. Oranje, Olivier Chosidow, Saravan Sacchidanand, Gail Todd, Krishnan Singh, Nicole Scangarella, Ribhi Shawar, and Monique Twynholm on behalf of the TOC 100224 Study Team. RET-09 Topical retapamulin ointment, 1%, versus sodium fusidate ointment, 2%, for impetigo: a randomized, observer-blinded, noninferiority study. Dermatology. 2007;215(4):331-340.
Nicole E Scangarella, Ribhi M Shawar, S Bouchillon, D Hoban. The microbiological profile of a new topical antibacterial, retapamulin ointment, 1% . Expert Rev Anti Infect Ther. 2009;7(3):269-279.
Medical condition
Skin Infections, Bacterial
Product
retapamulin
Collaborators
Not applicable
Study date(s)
April 2005 to September 2005
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
9+ years
Accepts healthy volunteers
No
- 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.
- Any signs and symptoms of systemic infection.
- Any serious underlying disease that could be imminently life threatening.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Exclusion criteria:
- Any signs and symptoms of systemic infection.
- Any serious underlying disease that could be imminently life threatening.
Trial location(s)
Location
GSK Investigational Site
Doebeln, Sachsen, Germany, 04720
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 50674
Status
Study Complete
Location
GSK Investigational Site
Muenchen, Bayern, Germany, 81241
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bonn, Nordrhein-Westfalen, Germany, 53177
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Muenchen, Bayern, Germany, 80801
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Gelsenkirchen, Nordrhein-Westfalen, Germany, 45879
Status
Study Complete
Location
GSK Investigational Site
Eloffsdal, Pretoria, South Africa, 0084
Status
Study Complete
Location
GSK Investigational Site
Kleve-Materborn, Nordrhein-Westfalen, Germany, 47533
Status
Study Complete
Location
GSK Investigational Site
Dresden, Sachsen, Germany, 01097
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Zapopan, Jalisco, Jalisco, Mexico, 45190
Status
Terminated/Withdrawn
Location
GSK Investigational Site
OUDE PEKELA, Netherlands, 9665 AR
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Winnipeg, Manitoba, Canada, R3C 0N2
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bad Honnef, Nordrhein-Westfalen, Germany, 53604
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Reichenbach, Sachsen, Germany, 08468
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Krefeld, Nordrhein-Westfalen, Germany, 47798
Status
Study Complete
Location
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany, 24148
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Gilching, Bayern, Germany, 82205
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Unna, Nordrhein-Westfalen, Germany, 59423
Status
Study Complete
Location
GSK Investigational Site
Duelmen, Niedersachsen, Germany, 48249
Status
Study Complete
Location
GSK Investigational Site
Saint John's, Newfoundland and Labrador, Canada, A1E 2C2
Status
Study Complete
Location
GSK Investigational Site
Rendsburg, Schleswig-Holstein, Germany, 24768
Status
Study Complete
Location
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany, 24103
Status
Study Complete
Location
GSK Investigational Site
Duesseldorf, Nordrhein-Westfalen, Germany, 40472
Status
Study Complete
Location
GSK Investigational Site
Sudbury, Ontario, Canada, P3E 6B4
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Worms, Rheinland-Pfalz, Germany, 67547
Status
Study Complete
Location
GSK Investigational Site
Wuppertal, Nordrhein-Westfalen, Germany, 42103
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Muelheim, Nordrhein-Westfalen, Germany, 45468
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Preetz, Schleswig-Holstein, Germany, 24211
Status
Study Complete
Location
GSK Investigational Site
Olpe, Nordrhein-Westfalen, Germany, 57462
Status
Terminated/Withdrawn
Study documents
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-09-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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