A New Formulation of Intravenous Paracetamol for Fever Management

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.

Conditions

• Fever

Interventions

DRUG

APOTEL max

The study drug is provided in a form of bag with 100ml final volume and it is directly connected to the infusion device that leads to a catheter already cannulated in one antecubital vein.

DRUG

Placebo

Placebo is provided in a form of bag with 100ml final volume and it is directly connected to the infusion device that leads to a catheter already cannulated in one antecubital vein. Placebo contains water for injection and inactive vehicles.

Sponsors & Collaborators

• Attikon Hospital

  collaborator OTHER

• University Hospital of Patras

  collaborator OTHER

• University Hospital of Crete

  collaborator OTHER

• Thriasio General Hospital of Elefsina

  collaborator OTHER

• General Hospital Of Thessaloniki Ippokratio

  collaborator OTHER

• General Hospital of Chalkida

  collaborator OTHER_GOV

• Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.

  lead INDUSTRY

Principal Investigators

• Dimitrios Boumpas, MD, PhD · Attikon Hospital

• Charalambos Gogos, MD, PhD · University Hospital of Patras

• George Samonis, MD, PhD · University Hospital of Crete

• Styliani Sympardi, MD · Thriasio General Hospital of Elefsina

• Asterios Karagiannis, MD, PhD · University Hospital of Thessaloniki Hippokrateion

• Nikolaos Tsokos, MD · General Hospital of Halkida

Study Design

Allocation

RANDOMIZED

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-02-28

Primary Completion

2016-03-31

Completion

2016-03-31

Countries

• Greece

Study Locations