A New Formulation of Intravenous Paracetamol for Fever Management

Phase 4 Completed 80 enrolled Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A. Attikon Hospital · collab General Hospital Of Thessaloniki Ippokratio · collab General Hospital of Chalkida · collab Thriasio General Hospital of Elefsina · collab University Hospital of Crete · collab University Hospital of Patras · collab

RandomizedParallel-groupDouble-blind

Summary

The efficacy of intravenous paracetamol has never been compared with other drugs for the management of fever due to infections. Available data come from clinical studies conducted in healthy volunteers subject to experimental endotoxemia. The present study compares the efficacy of the new ΑPOTEL Μax® formulation versus placebo for the management of fever of infectious origin.

Timeline

Start: 2015-02
Primary completion: 2016-03
Completion: 2016-03

Publications

Background Giamarellos-Bourboulis EJ, Spyridaki A, Savva A, Georgitsi M, Tsaganos T, Mouktaroudi M, Raftogiannis M, Antonopoulou A, Papaziogas V, Baziaka F, Sereti K, Christopoulos P, Marioli A, Kanni T, Maravitsa P, Pantelidou I, Leventogiannis K, Tsiaoussis P, Lymberopoulou K, Koutelidakis IM. Intravenous paracetamol as an antipyretic and analgesic medication: the significance of drug metabolism. J Pharmacol Sci. 2014;124(2):144-52. doi: 10.1254/jphs.13133fp. Epub 2014 Jan 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Acetaminophen	Small molecule	1 g	Intravenous

Indications

No indication recorded.