A New Formulation of Intravenous Paracetamol for Fever Management

NCT02283203 | Completed Phase 4

• 1 other identifier: APOTEL-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

Paracetamol; Management of fever; Infections

Outcome Measures

Primary Outcomes (1)

• Body temperature as a measure of to compare the efficacy of intravenously administered ΑPOTEL Μax® over placebo for the achievement of defervescence.

  The comparative efficacy of intravenously administered ΑPOTEL Μax® over placebo for the achievement of defervescence; defervescence is defined as any body temperature equal to or lower than 37.1 degC.

  3 hours

Secondary Outcomes (4)

• Need for the administration of rescue drug.

  30 hours

• Comparison of defervescence with the rescue drug in the paracetamol arm with the placebo arm

  30 hours

• Correlation between serum concentrations of free active paracetamol and metabolites with the clinical efficacy of paracetamol

  30 hours

• The administration of other antipyretics by the attending physicians after rescue drug in each study group

  30 hours

Study Arms (2)

APOTEL max

ACTIVE COMPARATOR

Active drug; water for injection at a volume of 100ml with added 1g of paracetamol and inactive ingredients (ΑPOTEL max®), infused within 15 minutes. Available in 100ml bags.

Drug: APOTEL max

Placebo

PLACEBO COMPARATOR

Placebo; water for injection at a volume of 100ml with added inactive ingredients, infused within 15 minutes. Available in 100ml bags.

Drug: Placebo

Interventions

APOTEL max DRUG

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.

Also known as: Paracetamol solution for infusion, 1gram per 100ml bag

APOTEL max

Placebo DRUG

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.

Also known as: Water for injection and vehicles

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent by the patient
• Patient of either gender
• Age equal to or greater than 18 years old
• Fever onset less than 24 hours
• Body temperature greater than or equal to 38.50C.
• Infection of the upper respiratory tract or of the lower respiratory tract or acute pyelonephritis or infection of the skin and soft tissues that can explain fever onset.

You may not qualify if:

• Age below 18 years old
• Denial for written consent
• Intake of paracetamol for any reason either orally or intravenously or intramuscularly the last 12 hours
• Intake of any non-steroidal anti-inflammatory drug the last 8 hours
• Intake of any steroidal anti-inflammatory drug the last 12 hours
• History of liver cirrhosis
• Serum creatinine greater than 3 mg/dl
• Aspartate aminotransferase more than 3 times greater than the upper normal limit for the hospital lab
• Known allergy to non-steroidal anti-inflammatory drugs or to paracetamol
• Pregnancy or lactation
• Active bleeding of the upper or the lower gastrointestinal tract
• Thrombocytopenia defined as any absolute platelet count below 50000/mm3.

Sponsors & Collaborators

• Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.: lead
• Attikon Hospital: collaborator
• University Hospital of Patras: collaborator
• University Hospital of Crete: collaborator
• Thriasio General Hospital of Elefsina: collaborator
• General Hospital Of Thessaloniki Ippokratio: collaborator
• General Hospital of Chalkida: collaborator

Study Sites (6)

General Hospital of Chalkida

Chalcis, 34100, Greece

Location

Attikon Hospital

Haidari/Athens, 12462, Greece

Location

University Hospital of Crete

Heraklion, 71110, Greece

Location

Thriasion Elefsis General Hospital

Magoula Attikis, 19018, Greece

Location

University Hospital of Patras

Rion/Patras, 26504, Greece

Location

General Hospital Of Thessaloniki Ippokratio

Thessaloniki, 54642, Greece

Location

Related Publications (1)

• 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.

  PMID: 24553403 BACKGROUND

MeSH Terms

Conditions

Fever; Infections

Interventions

Water; Injections

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Dimitrios Boumpas, MD, PhD

  Attikon Hospital

  PRINCIPAL INVESTIGATOR

• Charalambos Gogos, MD, PhD

  University Hospital of Patras

  PRINCIPAL INVESTIGATOR

• George Samonis, MD, PhD

  University Hospital of Crete

  PRINCIPAL INVESTIGATOR

• Styliani Sympardi, MD

  Thriasio General Hospital of Elefsina

  PRINCIPAL INVESTIGATOR

• Asterios Karagiannis, MD, PhD

  University Hospital of Thessaloniki Hippokrateion

  PRINCIPAL INVESTIGATOR

• Nikolaos Tsokos, MD

  General Hospital of Halkida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2014
• First Posted: November 5, 2014
• Study Start: February 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 22, 2016

Record last verified: 2016-03

Locations

GR (6)