AUGMENTIN 1gm In Skin And Soft Tissue Infection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00343135
First received: June 20, 2006
Last updated: November 21, 2012
Last verified: November 2012

June 20, 2006
November 21, 2012
December 2004
March 2005   (final data collection date for primary outcome measure)
Clinical response at 10 - 14 days post therapy [ Time Frame: 10 - 14 days ]
Clinical response at 10 - 14 days post therapy
Complete list of historical versions of study NCT00343135 on ClinicalTrials.gov Archive Site
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 ]
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)
Not Provided
Not Provided
 
AUGMENTIN 1gm In Skin And Soft Tissue Infection
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 to evaluate the effects of AUGMENTIN 1gm in the treatment of Skin and Soft tissue infections

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Skin Diseases, Infectious
  • Infection, Soft Tissue
Drug: amoxicillin/clavulanate potassium 1gm
amoxicillin/clavulanate potassium 1gm
Other Name: amoxicillin/clavulanate potassium 1gm
Experimental: ARM 1
Intervention: Drug: amoxicillin/clavulanate potassium 1gm
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
195
March 2005
March 2005   (final data collection date for primary outcome measure)

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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Pakistan
 
NCT00343135
103997
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2012

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