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NCT00343135 Clinical Trial

AUGMENTIN 1gm In Skin And Soft Tissue Infection

Skin Diseases, Infectious Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00343135
Other study ID # 103997
Secondary ID
Status Completed
Phase Phase 4
First received June 20, 2006
Last updated November 21, 2012
Start date December 2004
Est. completion date March 2005

Study information
Verified date November 2012
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Pakistan: Ministry of Health
Study type Interventional

Clinical Trial Summary

Study to evaluate the effects of AUGMENTIN 1gm in the treatment of Skin and Soft tissue infections

Recruitment information / eligibility
Status Completed
Enrollment 195
Est. completion date March 2005
Est. primary completion date March 2005
Accepts healthy volunteers No
Gender Both
Age group 12 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• amoxicillin/clavulanate potassium 1gm
amoxicillin/clavulanate potassium 1gm

Locations
Country Name City State
Pakistan GSK Investigational Site Karachi
Pakistan GSK Investigational Site Lahore
Pakistan GSK Investigational Site Lahore

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Pakistan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical response at 10 - 14 days post therapy 10 - 14 days
Secondary 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) 2 - 4 days
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