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FeverPhase 4NCT02283203

A New Formulation of Intravenous Paracetamol for Fever Management

A Phase 4 study testing APOTEL max in people with Fever, run by Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A. at 6 sites in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Fever
What is being tested?
APOTEL max
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
6 sitesGreece
Study dates
Feb 2015to Mar 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Greece6 sites

  • General Hospital of Chalkida

    Chalcis, 34100

  • Attikon Hospital

    Haidari/Athens, 12462

  • University Hospital of Crete

    Heraklion, 71110

  • Thriasion Elefsis General Hospital

    Magoula Attikis, 19018

  • University Hospital of Patras

    Rion/Patras, 26504

  • General Hospital Of Thessaloniki Ippokratio

    Thessaloniki, 54642

Other trials in Greece

About this study

Official title: A Double-blind, Randomized, Placebo-controlled Phase IV Clinical Study of the Efficacy and Safety of a New Formulation of Paracetamol for the Management of Fever of Infectious Origin

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.

Read the detailed description

A new formulation of paracetamol for intravenous administration has been manufactured in Greece by the industry Uni-Pharma (ΑPOTEL Μax®). According to this new formulation, 1g of paracetamol is provided as a flask diluted into 100ml volume with the possibility of immediate connection with the infusion device of the patient. This formulation provides the advantage of a dilution ready-to-use which equals considerable financial benefit; nursing staff is not pre-occupied with the preparation of dilutions and the amount of consumables required for the preparation of this dilution is significantly decreased. Taking into consideration that the antipyretic effect of intravenous paracetamol has never been studied compared with other agents in patients and available data come from studies in volunteers with experimental endotoxemia, the present study compares the efficacy of the new ΑPOTEL Μax® formulation versus placebo for the management of fever of infectious origin (fever due to infection of the upper respiratory tract, of the lower respiratory tract, acute pyelonephritis or of the skin and soft tissues).

Conditions
Fever
Being tested
APOTEL max, Placebo
Keywords
Paracetamol, Management of fever, Infections
Medical subject headings
Fever, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • APOTEL maxDrug

    Also called Paracetamol solution for infusion, 1gram per 100ml bag

    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.

  • PlaceboDrug

    Also called Water for injection and vehicles

    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.

Study groups in NCT02283203
Study groupRoleWhat they receive
APOTEL maxActive comparatorActive 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.
Receives: Drug: APOTEL max
PlaceboPlacebo comparatorPlacebo; water for injection at a volume of 100ml with added inactive ingredients, infused within 15 minutes. Available in 100ml bags.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 hours

Secondary outcomes (4)

  1. Need for the administration of rescue drug.

    The comparison between the two study groups on the frequency and time to administration of rescue drug.

    Measured: 30 hours

  2. Comparison of defervescence with the rescue drug in the paracetamol arm with the placebo arm

    The correlation between defervescence with the rescue drug with the efficacy of the initially administered type of study drug (placebo over active drug).

    Measured: 30 hours

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

    The correlation between the achievement of defervescence and the concentrations of free active paracetamol and its metabolites in the serum of the patients.

    Measured: 30 hours

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

    The correlation between achievement of defervescence with the rescue drug and the need of further administration of other drugs as antipyretics at the discretion of the attending physicians.

    Measured: 30 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2014 (estimated)
  2. Study startFeb 2015
  3. Primary completionMar 2016
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02283203
Sponsor's protocol ID
APOTEL-02
Status last verified
Mar 2016
First submitted
19 Oct 2014
Last updated
22 Mar 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 24553403

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing APOTEL max in people with Fever, run by Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A. at 6 sites in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body temperature as a measure of to compare the efficacy of intravenously administered ΑPOTEL Μax® over placebo for the achievement of defervescence. (time frame: 3 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02283203, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2016.

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