Study to Assess the Efficacy and Safety of Potassium Clavulanate/Amoxicillin in Children With Acute Bacterial Rhinosinusitis

PHASE3CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

August 30, 2013

Primary Completion Date

November 7, 2013

Study Completion Date

November 7, 2013

Conditions
Sinusitis, Acute
Interventions
DRUG

Amoxicillin-Potassium Clavulanate Combination

The drug is available in two sachets (CVA/AMPC Dry Syrup 0.505 g and CVA/AMPC Dry Syrup 1.01 g). CVA/AMPC Dry Syrup 1.01 g sachet contains 42.9 mg of Potassium Clavulanate and 600 mg of Amoxicillin Hydrate. It is a white to yellowish white powder and has strawberry flavor and it is white to yellowish white suspension when it is suspended before use.

Trial Locations (3)

272-0143

GSK Investigational Site, Chiba

279-0012

GSK Investigational Site, Chiba

125-0052

GSK Investigational Site, Tokyo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01934231 - Study to Assess the Efficacy and Safety of Potassium Clavulanate/Amoxicillin in Children With Acute Bacterial Rhinosinusitis | Biotech Hunter | Biotech Hunter