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Amoxicillin vs amoxicillin-clavulanate vs placebo in acute otitis media in children
2025-524259-30-00Phase 4Authorised
- Sponsor
- Pohjois-Savon hyvinvointialue
- Start
- Nov 2026
- Modality
- Small Molecules
- Countries
- 1
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Overview
Phase 4, randomised, triple-blind trial of amoxicillin, amoxicillin + clavulanic acid and clavulanic acid in acute otitis media (AOM) (3 arms), sponsored by Pohjois-Savon hyvinvointialue. Primary endpoint: Primary outcome: AOM-SOS score over days 1–7, 10, and 14. Planned start Nov 2026; status: authorised.
02
Drugs
amoxicillinamoxicillin + clavulanic acidclavulanic acid
03
Conditions
acute otitis media (AOM)
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