AUGMENTIN 1gm In Skin And Soft Tissue Infection
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00343135
First received: June 20, 2006
Last updated: November 21, 2012
Last verified: November 2012
| Tracking Information | |||||
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| First Received Date ICMJE | June 20, 2006 | ||||
| Last Updated Date | November 21, 2012 | ||||
| Start Date ICMJE | December 2004 | ||||
| Primary Completion Date | March 2005 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Clinical response at 10 - 14 days post therapy [ Time Frame: 10 - 14 days ] | ||||
| Original Primary Outcome Measures ICMJE |
Clinical response at 10 - 14 days post therapy | ||||
| Change History | Complete list of historical versions of study NCT00343135 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 |
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 Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | 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 |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: amoxicillin/clavulanate potassium 1gm
amoxicillin/clavulanate potassium 1gm
Other Name: amoxicillin/clavulanate potassium 1gm |
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| Study Arm (s) | Experimental: ARM 1
Intervention: Drug: amoxicillin/clavulanate potassium 1gm |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 195 | ||||
| Completion Date | March 2005 | ||||
| Primary Completion Date | March 2005 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 12 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Pakistan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00343135 | ||||
| Other Study ID Numbers ICMJE | 103997 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | GlaxoSmithKline | ||||
| Study Sponsor ICMJE | GlaxoSmithKline | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | GlaxoSmithKline | ||||
| Verification Date | November 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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