Clinical Trial Results:
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
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Summary
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EudraCT number |
2014-002588-14 |
Trial protocol |
GR |
Global end of trial date |
19 Mar 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
26 Nov 2021
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First version publication date |
26 Nov 2021
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Other versions |
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Summary report(s) |
Giamarellos2017 |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
APOTEL-02
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02283203 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories SA
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Sponsor organisation address |
14th Km National Road 1, Kifissia, Greece, 14564
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Public contact |
Regulatory Affairs department, Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories SA, 30 2108072512, unipharma@uni-pharma.gr
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Scientific contact |
Regulatory Affairs department, Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories SA, 30 2108072512, unipharma@uni-pharma.gr
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
11 Jul 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
19 Mar 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
19 Mar 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
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.
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Protection of trial subjects |
Administration of 1 g paracetamol as rescue medication (APOTEL MAX) 3 h after the start of the study drug infusion on patient demand or at the discretion of the attending physician.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Sep 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Greece: 80
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Worldwide total number of subjects |
80
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EEA total number of subjects |
80
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
65
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From 65 to 84 years |
15
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85 years and over |
0
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Recruitment
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Recruitment details |
The first patient was enrolled on February 18th 2015 and the last on March 19th 2016, in 5 centers in Greece. In total, 39 patients were randomized to the placebo arm and 41 to the paracetamol arm. | |||||||||
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Pre-assignment
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Screening details |
In total, 231 patients were asked to provide written consent for assessment of eligibility, and 185 provided this. As intense follow-up of enrolled patients was mandated as per the protocol, once a patient had been enrolled, no screening was run in parallel, to avoid mistakes by the study personnel during follow-up. | |||||||||
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Period 1
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Period 1 title |
First visit
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator | |||||||||
Blinding implementation details |
The study drugs (placebo or active drug) were constructed by the sponsor to be visually similar. A separate allocation sequence was designed for each study site by an independent statistician, who was the only holder of the allocation sequence.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo group | |||||||||
Arm description |
Patients were randomly assigned to the placebo group, receiving excipients diluted in water for injection at a volume of 100 ml and infused within 15 min. The specific excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Parenteral use
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Dosage and administration details |
Polypropylene bag with a final volume of 100 ml, which was connected directly to the infusion device that led to a catheter already cannulated in one antecubital vein. Infused within 15 min.
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Arm title
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Active drug group | |||||||||
Arm description |
Patients were randomly assigned to active drug group receiving 1 g paracetamol (Apotel max, Uni-Pharma SA) diluted in water for injection at a volume of 100ml and infused within 15 min. The inactive excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Apotel max
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Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Parenteral use
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Dosage and administration details |
Polypropylene bag with a final volume of 100 ml, which was connected directly to the infusion device that led to a catheter already cannulated in one antecubital vein. Infused within 15 min.
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Period 2
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Period 2 title |
Second visit-0.5h postinfusion
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Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo group | |||||||||
Arm description |
Patients were randomly assigned to the placebo group, receiving excipients diluted in water for injection at a volume of 100 ml and infused within 15 min. The specific excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Parenteral use
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Dosage and administration details |
Polypropylene bag with a final volume of 100 ml, which was connected directly to the infusion device that led to a catheter already cannulated in one antecubital vein. Infused within 15 min.
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Arm title
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Active drug group | |||||||||
Arm description |
Patients were randomly assigned to active drug group receiving 1 g paracetamol (Apotel max, Uni-Pharma SA) diluted in water for injection at a volume of 100ml and infused within 15 min. The inactive excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Apotel max
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Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Parenteral use
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Dosage and administration details |
Polypropylene bag with a final volume of 100 ml, which was connected directly to the infusion device that led to a catheter already cannulated in one antecubital vein. Infused within 15 min.
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Period 3
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Period 3 title |
Third visit-1h postinfusion
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Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo group | |||||||||
Arm description |
Patients were randomly assigned to the placebo group, receiving excipients diluted in water for injection at a volume of 100 ml and infused within 15 min. The specific excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Parenteral use
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Dosage and administration details |
Polypropylene bag with a final volume of 100 ml, which was connected directly to the infusion device that led to a catheter already cannulated in one antecubital vein. Infused within 15 min.
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Arm title
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Active drug group | |||||||||
Arm description |
Patients were randomly assigned to active drug group receiving 1 g paracetamol (Apotel max, Uni-Pharma SA) diluted in water for injection at a volume of 100ml and infused within 15 min. The inactive excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Apotel max
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Investigational medicinal product code |
||||||||||
Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Parenteral use
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Dosage and administration details |
Polypropylene bag with a final volume of 100 ml, which was connected directly to the infusion device that led to a catheter already cannulated in one antecubital vein. Infused within 15 min.
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Period 4
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Period 4 title |
Fourth visit-2h postinfusion
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Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo group | |||||||||
Arm description |
Patients were randomly assigned to the placebo group, receiving excipients diluted in water for injection at a volume of 100 ml and infused within 15 min. The specific excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Parenteral use
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Dosage and administration details |
Polypropylene bag with a final volume of 100 ml, which was connected directly to the infusion device that led to a catheter already cannulated in one antecubital vein. Infused within 15 min.
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Arm title
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Active drug group | |||||||||
Arm description |
Patients were randomly assigned to active drug group receiving 1 g paracetamol (Apotel max, Uni-Pharma SA) diluted in water for injection at a volume of 100ml and infused within 15 min. The inactive excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Apotel max
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Investigational medicinal product code |
||||||||||
Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Parenteral use
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Dosage and administration details |
Polypropylene bag with a final volume of 100 ml, which was connected directly to the infusion device that led to a catheter already cannulated in one antecubital vein. Infused within 15 min.
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Period 5
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Period 5 title |
Fifth visit-3h postinfusion
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Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo group | |||||||||
Arm description |
Patients were randomly assigned to the placebo group, receiving excipients diluted in water for injection at a volume of 100 ml and infused within 15 min. The specific excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Parenteral use
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Dosage and administration details |
Polypropylene bag with a final volume of 100 ml, which was connected directly to the infusion device that led to a catheter already cannulated in one antecubital vein. Infused within 15 min.
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Arm title
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Active drug group | |||||||||
Arm description |
Patients were randomly assigned to active drug group receiving 1 g paracetamol (Apotel max, Uni-Pharma SA) diluted in water for injection at a volume of 100ml and infused within 15 min. The inactive excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Apotel max
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Investigational medicinal product code |
||||||||||
Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Parenteral use
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Dosage and administration details |
Polypropylene bag with a final volume of 100 ml, which was connected directly to the infusion device that led to a catheter already cannulated in one antecubital vein. Infused within 15 min.
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Period 6
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Period 6 title |
Sixth visit-4h postinfusion
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Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo group | |||||||||
Arm description |
Patients were randomly assigned to the placebo group, receiving excipients diluted in water for injection at a volume of 100 ml and infused within 15 min. The specific excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
||||||||||
Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Parenteral use
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Dosage and administration details |
Polypropylene bag with a final volume of 100 ml, which was connected directly to the infusion device that led to a catheter already cannulated in one antecubital vein. Infused within 15 min.
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Arm title
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Active drug group | |||||||||
Arm description |
Patients were randomly assigned to active drug group receiving 1 g paracetamol (Apotel max, Uni-Pharma SA) diluted in water for injection at a volume of 100ml and infused within 15 min. The inactive excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Apotel max
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Investigational medicinal product code |
||||||||||
Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Parenteral use
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Dosage and administration details |
Polypropylene bag with a final volume of 100 ml, which was connected directly to the infusion device that led to a catheter already cannulated in one antecubital vein. Infused within 15 min.
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Period 7
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Period 7 title |
Seventh visit-5h postinfusion
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Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo group | |||||||||
Arm description |
Patients were randomly assigned to the placebo group, receiving excipients diluted in water for injection at a volume of 100 ml and infused within 15 min. The specific excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Solution for infusion
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|||||||||
Routes of administration |
Parenteral use
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|||||||||
Dosage and administration details |
Polypropylene bag with a final volume of 100 ml, which was connected directly to the infusion device that led to a catheter already cannulated in one antecubital vein. Infused within 15 min.
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Arm title
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Active drug group | |||||||||
Arm description |
Patients were randomly assigned to active drug group receiving 1 g paracetamol (Apotel max, Uni-Pharma SA) diluted in water for injection at a volume of 100ml and infused within 15 min. The inactive excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Apotel max
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Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Solution for infusion
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|||||||||
Routes of administration |
Parenteral use
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|||||||||
Dosage and administration details |
Polypropylene bag with a final volume of 100 ml, which was connected directly to the infusion device that led to a catheter already cannulated in one antecubital vein. Infused within 15 min.
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Period 8
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Period 8 title |
Eighth visit-6h postinfusion
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Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo group | |||||||||
Arm description |
Patients were randomly assigned to the placebo group, receiving excipients diluted in water for injection at a volume of 100 ml and infused within 15 min. The specific excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Solution for infusion
|
|||||||||
Routes of administration |
Parenteral use
|
|||||||||
Dosage and administration details |
Polypropylene bag with a final volume of 100 ml, which was connected directly to the infusion device that led to a catheter already cannulated in one antecubital vein. Infused within 15 min.
|
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Arm title
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Active drug group | |||||||||
Arm description |
Patients were randomly assigned to active drug group receiving 1 g paracetamol (Apotel max, Uni-Pharma SA) diluted in water for injection at a volume of 100ml and infused within 15 min. The inactive excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Apotel max
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Solution for infusion
|
|||||||||
Routes of administration |
Parenteral use
|
|||||||||
Dosage and administration details |
Polypropylene bag with a final volume of 100 ml, which was connected directly to the infusion device that led to a catheter already cannulated in one antecubital vein. Infused within 15 min.
|
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Baseline characteristics reporting groups
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Reporting group title |
Placebo group
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Reporting group description |
Patients were randomly assigned to the placebo group, receiving excipients diluted in water for injection at a volume of 100 ml and infused within 15 min. The specific excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Active drug group
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Reporting group description |
Patients were randomly assigned to active drug group receiving 1 g paracetamol (Apotel max, Uni-Pharma SA) diluted in water for injection at a volume of 100ml and infused within 15 min. The inactive excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Placebo group
|
||
Reporting group description |
Patients were randomly assigned to the placebo group, receiving excipients diluted in water for injection at a volume of 100 ml and infused within 15 min. The specific excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | ||
Reporting group title |
Active drug group
|
||
Reporting group description |
Patients were randomly assigned to active drug group receiving 1 g paracetamol (Apotel max, Uni-Pharma SA) diluted in water for injection at a volume of 100ml and infused within 15 min. The inactive excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | ||
Reporting group title |
Placebo group
|
||
Reporting group description |
Patients were randomly assigned to the placebo group, receiving excipients diluted in water for injection at a volume of 100 ml and infused within 15 min. The specific excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | ||
Reporting group title |
Active drug group
|
||
Reporting group description |
Patients were randomly assigned to active drug group receiving 1 g paracetamol (Apotel max, Uni-Pharma SA) diluted in water for injection at a volume of 100ml and infused within 15 min. The inactive excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | ||
Reporting group title |
Placebo group
|
||
Reporting group description |
Patients were randomly assigned to the placebo group, receiving excipients diluted in water for injection at a volume of 100 ml and infused within 15 min. The specific excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | ||
Reporting group title |
Active drug group
|
||
Reporting group description |
Patients were randomly assigned to active drug group receiving 1 g paracetamol (Apotel max, Uni-Pharma SA) diluted in water for injection at a volume of 100ml and infused within 15 min. The inactive excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | ||
Reporting group title |
Placebo group
|
||
Reporting group description |
Patients were randomly assigned to the placebo group, receiving excipients diluted in water for injection at a volume of 100 ml and infused within 15 min. The specific excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | ||
Reporting group title |
Active drug group
|
||
Reporting group description |
Patients were randomly assigned to active drug group receiving 1 g paracetamol (Apotel max, Uni-Pharma SA) diluted in water for injection at a volume of 100ml and infused within 15 min. The inactive excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | ||
Reporting group title |
Placebo group
|
||
Reporting group description |
Patients were randomly assigned to the placebo group, receiving excipients diluted in water for injection at a volume of 100 ml and infused within 15 min. The specific excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | ||
Reporting group title |
Active drug group
|
||
Reporting group description |
Patients were randomly assigned to active drug group receiving 1 g paracetamol (Apotel max, Uni-Pharma SA) diluted in water for injection at a volume of 100ml and infused within 15 min. The inactive excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | ||
Reporting group title |
Placebo group
|
||
Reporting group description |
Patients were randomly assigned to the placebo group, receiving excipients diluted in water for injection at a volume of 100 ml and infused within 15 min. The specific excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | ||
Reporting group title |
Active drug group
|
||
Reporting group description |
Patients were randomly assigned to active drug group receiving 1 g paracetamol (Apotel max, Uni-Pharma SA) diluted in water for injection at a volume of 100ml and infused within 15 min. The inactive excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | ||
Reporting group title |
Placebo group
|
||
Reporting group description |
Patients were randomly assigned to the placebo group, receiving excipients diluted in water for injection at a volume of 100 ml and infused within 15 min. The specific excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | ||
Reporting group title |
Active drug group
|
||
Reporting group description |
Patients were randomly assigned to active drug group receiving 1 g paracetamol (Apotel max, Uni-Pharma SA) diluted in water for injection at a volume of 100ml and infused within 15 min. The inactive excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | ||
Reporting group title |
Placebo group
|
||
Reporting group description |
Patients were randomly assigned to the placebo group, receiving excipients diluted in water for injection at a volume of 100 ml and infused within 15 min. The specific excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | ||
Reporting group title |
Active drug group
|
||
Reporting group description |
Patients were randomly assigned to active drug group receiving 1 g paracetamol (Apotel max, Uni-Pharma SA) diluted in water for injection at a volume of 100ml and infused within 15 min. The inactive excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | ||
|
|||||||||||||
End point title |
Achievement of defervescence [1] | ||||||||||||
End point description |
Percentage of patients found with sustained defervescence during the 6-h follow-up. Achievement of defervescence was defined as any core body temperature ≤37.1°C.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
6 h after administration
|
||||||||||||
| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Comparisons of the advent of defervescence and of the need for rescue medication between the groups were carried out using the Fisher exact test |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Time to defervescence [2] | ||||||||||||
End point description |
Median time to defervescence
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
6 hours after administration
|
||||||||||||
| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The median and interquartile ranges of time to the advent of defervescence and to the need for rescue medication were measured after Kaplan–Meier analysis |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Rescue medication | ||||||||||||
End point description |
Need for administration of rescue medication
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
6 hours after administration
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
||||||||||||||||||||||||||||||||||
|
Adverse events information
|
||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
10 days after administration
|
|||||||||||||||||||||||||||||||||
Assessment type |
Systematic | |||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||
Dictionary version |
17.0
|
|||||||||||||||||||||||||||||||||
|
Reporting groups
|
||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo group
|
|||||||||||||||||||||||||||||||||
Reporting group description |
Patients were randomly assigned to the placebo group, receiving excipients diluted in water for injection at a volume of 100 ml and infused within 15 min. The specific excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | |||||||||||||||||||||||||||||||||
Reporting group title |
Active drug group
|
|||||||||||||||||||||||||||||||||
Reporting group description |
Patients were randomly assigned to active drug group receiving 1 g paracetamol (Apotel max, Uni-Pharma SA) diluted in water for injection at a volume of 100ml and infused within 15 min. The inactive excipients were hydroxypropylbetadex, monothioglycerol, disodium edetate, sodium chloride and disodium phosphate dihydrate. | |||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
Online references |
|||
| http://www.ncbi.nlm.nih.gov/pubmed/27792836 |
|||
