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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 18, 2006 | ||||
| Last Updated Date | October 6, 2008 | ||||
| Start Date ICMJE | January 2006 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Pharmacokinetic data on amoxicillin/clavulanate [ Time Frame: Time above MIC (T>MIC)for amoxicillin when amoxicillin/clavulanate is given orally twice daily to adolescents. ] | ||||
| Original Primary Outcome Measures ICMJE |
Pharmacokinetic data on amoxicillin/clavulanate Time above MIC (T>MIC)for amoxicillin when amoxicillin/clavulanate is given orally twice daily to adolescents. | ||||
| Change History | Complete list of historical versions of study NCT00354965 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Safety, tolerability, and clinical response of oral amoxicillin/clavulanate [ Time Frame: twice daily for 10 days in adolescent patients. ] | ||||
| Original Secondary Outcome Measures ICMJE |
Safety, tolerability, and clinical response of oral amoxicillin/clavulanate twice daily for 10 days in adolescent patients. | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Pharmacokinetic Profiles Of Amoxicillin 2000 mg And Clavulanate 125 mg In Adolescent Patients | ||||
| Official Title ICMJE | An Open-Label Study to Determine the Pharmacokinetic Profiles of Amoxicillin and Clavulanate in Adolescent Patients Weighing at Least 40 kg and no More Than 16 Years of Age Receiving Augmentin XR (Amoxicillin 2000 mg/Clavulanate 125 mg) Orally Twice Daily for 10 Days. | ||||
| Brief Summary | Clinical research study to test amoxicillin and clavulanate tablet formulation for use in Acute Bacterial Sinusitis (ABS) in adolescent patients weighing at least 40 kilogram (kg) and no more than 16 years old. ABS is an acute bacterial infection of the sinus. The purpose of this study is to find out how children tolerate Augmentin XR and what happens to Augmentin XR in the body after it has been swallowed by children. |
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| Detailed Description | |||||
| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study | ||||
| Condition ICMJE | Sinusitis, Acute Bacterial | ||||
| Intervention ICMJE | Drug: amoxicillin/clavulanate potassium | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 52 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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| Gender | Both | ||||
| Ages | up to 16 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00354965 | ||||
| Responsible Party | Study Director, GSK | ||||
| Study ID Numbers ICMJE | AUG102821 | ||||
| Study Sponsor ICMJE | GlaxoSmithKline | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | GlaxoSmithKline | ||||
| Verification Date | October 2008 | ||||
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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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