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AUGMENTIN 1gm In Skin And Soft Tissue Infection

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: June 20, 2006
Last updated: November 21, 2012
Last verified: November 2012
Study to evaluate the effects of AUGMENTIN 1gm in the treatment of Skin and Soft tissue infections

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

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

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) [ Time Frame: 2 - 4 days ]

Enrollment: 195
Study Start Date: December 2004
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARM 1 Drug: amoxicillin/clavulanate potassium 1gm
amoxicillin/clavulanate potassium 1gm


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00343135

GSK Investigational Site
Karachi, Pakistan
GSK Investigational Site
Lahore, Pakistan, 54000
GSK Investigational Site
Lahore, Pakistan
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00343135     History of Changes
Other Study ID Numbers: 103997
Study First Received: June 20, 2006
Last Updated: November 21, 2012

Keywords provided by GlaxoSmithKline:

Additional relevant MeSH terms:
Communicable Diseases
Skin Diseases
Soft Tissue Infections
Skin Diseases, Infectious
Clavulanic Acid
Clavulanic Acids
Amoxicillin-Potassium Clavulanate Combination
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017