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AUGMENTIN 1gm In Skin And Soft Tissue Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00343135
Recruitment Status : Completed
First Posted : June 22, 2006
Last Update Posted : November 22, 2012
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:
Study to evaluate the effects of AUGMENTIN 1gm in the treatment of Skin and Soft tissue infections

Condition or disease Intervention/treatment Phase
Skin Diseases, Infectious Infection, Soft Tissue Drug: amoxicillin/clavulanate potassium 1gm Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 195 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open, Non-comparative Study to Evaluate the Efficacy and Safety of AUGMENTIN 1gm (875mg Amoxicillin/125mg Clavulanic Acid) po q 12 Hours in the Treatment of Uncomplicated Skin and Soft Tissue Infections in Pakistan
Study Start Date : December 2004
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arms and Interventions
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Arm Intervention/treatment
Experimental: ARM 1 Drug: amoxicillin/clavulanate potassium 1gm
amoxicillin/clavulanate potassium 1gm


Outcome Measures
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Primary Outcome Measures :
  1. Clinical response at 10 - 14 days post therapy [ Time Frame: 10 - 14 days ]

Secondary Outcome Measures :
  1. Clinical response at on-therapy evaluation visit (2 - 4 days following initiation of therapy and 48 - 96 hours post therapy) Bacteriological response at (2 - 4 days following initiation of therapy, 48 - 96 hours post therapy, 10 - 14 days post therapy) [ Time Frame: 2 - 4 days ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • having diagnosed uncomplicated soft tissue infection (e.g furuncle, cellulitis)
  • has given freely documented consent.

Exclusion Criteria:

  • antibiotics
  • have renal or hepatic insufficiency
  • systemic toxicity
  • pregnancy
  • lactation
  • hypersensitivity to penicillin or Beta-lactam antibiotics
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00343135


Locations
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Pakistan
GSK Investigational Site
Karachi, Pakistan
GSK Investigational Site
Lahore, Pakistan, 54000
GSK Investigational Site
Lahore, Pakistan
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00343135    
Other Study ID Numbers: 103997
First Posted: June 22, 2006    Key Record Dates
Last Update Posted: November 22, 2012
Last Verified: November 2012
Keywords provided by GlaxoSmithKline:
Skin
AUGMENTIN
1gm
 Soft
tissue
Infections
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Soft Tissue Infections
Skin Diseases, Infectious
Skin Diseases
Disease Attributes
Pathologic Processes
Amoxicillin
 Clavulanic Acid
Clavulanic Acids
Amoxicillin-Potassium Clavulanate Combination
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action