NCT04600752View on ClinicalTrials.gov

Study to Evaluate the Safety and Clinical Efficacy of Augmentin® Extra Strength-600 in Children With Acute Otitis Media in India

PHASE4CompletedINTERVENTIONAL
Enrollment

310

Participants

Timeline

Start Date

May 7, 2022

Primary Completion Date

November 12, 2022

Study Completion Date

November 12, 2022

Conditions
Otitis MediaInfections, Respiratory TractRespiratory Tract Infections
Interventions
DRUG

Augmentin (ES)-600

Augmentin ES will be administered as reconstituted oral suspension containing Amoxicillin and Potassium Clavulanate 600 mg/42.9 mg per 5 milliliters.

Trial Locations (13)

110002

GSK Investigational Site, New Delhi

141008

GSK Investigational Site, Ludhiana

208002

GSK Investigational Site, Kanpur

221001

GSK Investigational Site, Varanasi

302016

GSK Investigational Site, Jaipur

411030

GSK Investigational Site, Purne

411043

GSK Investigational Site, Pune

440009

GSK Investigational Site, Nagpur

492099

GSK Investigational Site, Raipur

500018

GSK Investigational Site, Hyderabad

590010

GSK Investigational Site, Belgaun

625107

GSK Investigational Site, Madurai

700017

GSK Investigational Site, Kolkata

Sponsors

Lead Sponsor

GlaxoSmithKline
All Listed Sponsors
collaborator

Iqvia Pty Ltd

INDUSTRY

lead

GlaxoSmithKline

INDUSTRY

NCT04600752 - Study to Evaluate the Safety and Clinical Efficacy of Augmentin® Extra Strength-600 in Children With Acute Otitis Media in India | Biotech Hunter | Biotech Hunter