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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

Tracking Information
First Submitted Date  ICMJE June 20, 2006
First Posted Date  ICMJE June 22, 2006
Last Update Posted Date November 22, 2012
Study Start Date  ICMJE December 2004
Actual Primary Completion Date March 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2010)
Clinical response at 10 - 14 days post therapy [ Time Frame: 10 - 14 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 20, 2006)
Clinical response at 10 - 14 days post therapy
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2010)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2006)
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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AUGMENTIN 1gm In Skin And Soft Tissue Infection
Official Title  ICMJE 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
Brief Summary Study to evaluate the effects of AUGMENTIN 1gm in the treatment of Skin and Soft tissue infections
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Skin Diseases, Infectious
  • Infection, Soft Tissue
Intervention  ICMJE Drug: amoxicillin/clavulanate potassium 1gm
amoxicillin/clavulanate potassium 1gm
Study Arms  ICMJE Experimental: ARM 1
Intervention: Drug: amoxicillin/clavulanate potassium 1gm
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 4, 2008)
195
Original Enrollment  ICMJE
 (submitted: June 20, 2006)
200
Actual Study Completion Date  ICMJE March 2005
Actual Primary Completion Date March 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00343135
Other Study ID Numbers  ICMJE 103997
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP