A Phase 1 interventional study of amoxicillin/clavulanate potassium in Infections, Respiratory Tract, sponsored by GlaxoSmithKline. Completed at 6 sites in United States. Open to participants aged Up to 16 Years. Per ClinicalTrials.gov, last updated 2017-08-01.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment
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.
1,031 studies on the registry are indexed under Respiratory Tract Infections; 144 are open to participants now.
This study's enrollment of 52 is below the median of 199 across 698 interventional studies indexed under Respiratory Tract Infections.
Browse Respiratory Tract Infections studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Drug: amoxicillin/clavulanate potassium
amoxicillin/clavulanate potassium
Pharmacokinetic data on amoxicillin/clavulanate
Time frame: Time above MIC (T>MIC)for amoxicillin when amoxicillin/clavulanate is given orally twice daily to adolescents.
Safety, tolerability, and clinical response of oral amoxicillin/clavulanate
Time frame: twice daily for 10 days in adolescent patients.
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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GlaxoSmithKline