Back to resultsAUGMENTIN 1gm In Skin And Soft Tissue Infection
Primary Purpose
Skin Diseases, Infectious, Infection, Soft Tissue
Status
Completed
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
amoxicillin/clavulanate potassium 1gm
Sponsored by
About this trial
This is an interventional treatment trial for Skin Diseases, Infectious focused on measuring Skin, AUGMENTIN, 1gm, Soft, tissue, Infections
Eligibility 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
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ARM 1
Arm Description
Outcomes
Primary Outcome Measures
Clinical response at 10 - 14 days post therapy
Secondary Outcome Measures
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00343135
Brief Title
AUGMENTIN 1gm In Skin And Soft Tissue Infection
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 Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
Study to evaluate the effects of AUGMENTIN 1gm in the treatment of Skin and Soft tissue infections
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Diseases, Infectious, Infection, Soft Tissue
Keywords
Skin, AUGMENTIN, 1gm, Soft, tissue, Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
195 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ARM 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
amoxicillin/clavulanate potassium 1gm
Intervention Description
amoxicillin/clavulanate potassium 1gm
Primary Outcome Measure Information:
Title
Clinical response at 10 - 14 days post therapy
Time Frame
10 - 14 days
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Karachi
Country
Pakistan
Facility Name
GSK Investigational Site
City
Lahore
ZIP/Postal Code
54000
Country
Pakistan
Facility Name
GSK Investigational Site
City
Lahore
Country
Pakistan
12. IPD Sharing Statement
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AUGMENTIN 1gm In Skin And Soft Tissue Infection
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