A New Formulation of Intravenous Paracetamol for Fever Management

March 21, 2016 updated by: Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Chalkida, Greece, 34100
        • General Hospital of Chalkida
      • Haidari/Athens, Greece, 12462
        • Attikon Hospital
      • Herakleion, Greece, 71110
        • University Hospital of Crete
      • Magoula Attikis, Greece, 19018
        • Thriasion Elefsis General Hospital
      • Rion/Patras, Greece, 26504
        • University Hospital of Patras
      • Thessaloniki, Greece, 54642
        • General Hospital of Thessaloniki Ippokratio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Written informed consent by the patient
  2. Patient of either gender
  3. Age equal to or greater than 18 years old
  4. Fever onset less than 24 hours
  5. Body temperature greater than or equal to 38.50C.
  6. 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: APOTEL max
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
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.
Other Names:
  • Paracetamol solution for infusion, 1gram per 100ml bag
Placebo Comparator: Placebo
Placebo; water for injection at a volume of 100ml with added inactive ingredients, infused within 15 minutes. Available in 100ml bags.
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.
Other Names:
  • Water for injection and vehicles

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Need for the administration of rescue drug.
Time Frame: 30 hours
The comparison between the two study groups on the frequency and time to administration of rescue drug.
30 hours
Comparison of defervescence with the rescue drug in the paracetamol arm with the placebo arm
Time Frame: 30 hours
The correlation between defervescence with the rescue drug with the efficacy of the initially administered type of study drug (placebo over active drug).
30 hours
Correlation between serum concentrations of free active paracetamol and metabolites with the clinical efficacy of paracetamol
Time Frame: 30 hours
The correlation between the achievement of defervescence and the concentrations of free active paracetamol and its metabolites in the serum of the patients.
30 hours
The administration of other antipyretics by the attending physicians after rescue drug in each study group
Time Frame: 30 hours
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.
30 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital of Crete
University Hospital of Patras
Attikon Hospital
Thriasion Elefsis General Hospital
General Hospital Of Thessaloniki Ippokratio
General Hospital of Chalkida

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Charalambos Gogos, MD, PhD, University Hospital of Patras
  • Principal Investigator: Dimitrios Boumpas, MD, PhD, Attikon Hospital
  • Principal Investigator: George Samonis, MD, PhD, University Hospital of Crete
  • Principal Investigator: Styliani Sympardi, MD, Thriasion Elefsis General Hospital
  • Principal Investigator: Asterios Karagiannis, MD, PhD, University Hospital of Thessaloniki Hippokrateion
  • Principal Investigator: Nikolaos Tsokos, MD, General Hospital of Halkida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APOTEL-02

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