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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
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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
Other Name: amoxicillin/clavulanate potassium 1gm

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00343135

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00343135     History of Changes
Other Study ID Numbers: 103997
Study First Received: June 20, 2006
Last Updated: November 21, 2012
Health Authority: Pakistan: Ministry of Health

Keywords provided by GlaxoSmithKline:
Skin
AUGMENTIN
1gm
 Soft
tissue
Infections

Additional relevant MeSH terms:
Communicable Diseases
Infection
Skin Diseases
Skin Diseases, Infectious
Soft Tissue Infections
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acids
 Clavulanic Acid
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013