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    Summary
    EudraCT Number:2014-002588-14
    Sponsor's Protocol Code Number:APOTEL-02
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-08-20
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGreece - EOF
    A.2EudraCT number2014-002588-14
    A.3Full title of the trial
    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
    ΜΙΑ ΔΙΠΛΗ-ΤΥΦΛΗ, ΤΥΧΑΙΟΠΟΙΗΜΕΝΗ, ΕΛΕΓΧΟΜΕΝΗ ΜΕ ΕΙΚΟΝΙΚΟ ΦΑΡΜΑΚΟ ΚΛΙΝΙΚΗ ΜΕΛΕΤΗ ΦΑΣΕΩΣ IV ΤΗΣ ΑΠΟΤΕΛΕΣΜΑΤΙΚΟΤΗΤΑΣ ΚΑΙ ΤΗΣ ΑΣΦΑΛΕΙΑΣ ΜΙΑΣ ΝΕΑΣ ΕΝΔΟΦΛΕΒΙΑΣ ΦΑΡΜΑΚΟΤΕΧΝΙΚΗΣ ΜΟΡΦΗΣ ΤΗΣ ΠΑΡΑΚΕΤΑΜΟΛΗΣ ΓΙΑ ΤΗΝ ΑΝΤΙΜΕΤΩΠΙΣΗ ΤΟΥ ΠΥΡΕΤΟΥ ΣΕ ΑΣΘΕΝΕΙΣ ΜΕ ΛΟΙΜΩΞΕΙΣ
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PARACETAMOL FOR THE MANAGEMENT OF FEVER
    Η ΠΑΡΑΚΕΤΑΜΟΛΗ ΩΣ ΑΝΤΙΠΥΡΕΤΙΚΟ ΦΑΡΜΑΚΟ
    A.3.2Name or abbreviated title of the trial where available
    UPH-APOTEL-2014-01
    A.4.1Sponsor's protocol code numberAPOTEL-02
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUNI-PHARMA SA
    B.1.3.4CountryGreece
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUni-Pharma SA
    B.4.2CountryGreece
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUni-Pharma SA
    B.5.2Functional name of contact pointRegulatory Affairs department
    B.5.3 Address:
    B.5.3.1Street Address14th Km National Road 1
    B.5.3.2Town/ cityKifissia/Athens
    B.5.3.3Post code14564
    B.5.3.4CountryGreece
    B.5.4Telephone number302108072512
    B.5.5Fax number302108078907
    B.5.6E-mailunipharma@uni-pharma.gr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name APOTEL max solution for infusion 1g/100ml
    D.2.1.1.2Name of the Marketing Authorisation holderUni-Pharma SA
    D.2.1.2Country which granted the Marketing AuthorisationGreece
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNParacetamol
    D.3.9.1CAS number 103-90-2
    D.3.9.3Other descriptive namePARACETAMOL
    D.3.9.4EV Substance CodeSUB09611MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Fever due to infection of the upper respiratory tract, of the lower respiratory tract, acute pyelonephritis or of the skin and soft tissues.
    Πυρετός λόγω λοίμωξης του ανώτερου αναπνευστικού συστήματος, του κατώτερου αναπνευστικού συστήματος, του ανώτερου ουροποιητικού συστήματος ή δέρματος/μαλακών μορίων
    E.1.1.1Medical condition in easily understood language
    Fever due to infections
    Πυρετός λόγω λοίμωξης
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10049541
    E.1.2Term Antipyresis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.
    Mία νέα φαρμακοτεχνική μορφή της ενδοφλεβίως χορηγούμενης παρακεταμόλης έχει παρασκευασθεί από την εταιρεία Uni-Pharma (ΑPOTEL Μax®). Στη μορφή αυτή, ποσότητα ίση με 1g παρακεταμόλης βρίσκεται διαλελυμένη σε 100ml με δυνατότητα άμεσης σύνδεσης στη συσκευή ενδοφλέβιας χορήγησης υγρών. H φαρμακοτεχνική αυτή μορφή περέχει σημαντικό φαρμακοοικονομικό πλεονέκτημα επειδή παρέχει έτοιμο διάλυμα προς εφαρμογή. Με αυτό τον τρόπο αφενός περιορίζεται η κόπωση του νοσηλευτικού προσωπικού προς παρασκευή διαλύματος προς χορήγηση και αφετέρου μειώνονται τα αναλώσιμα που θα χρησιμοποιούνταν για την παρασκευή διαλύματος προς χορήγηση. Δεδομένου ότι η αποτελεσματικότητα της ενδοφλεβίου χορηγούμενης παρακεταμόλης δεν έχει ποτέ μελετηθεί συγκριτικά με άλλο σκεύασμα για την αντιμετώπιση του πυρετού σε ασθενείς με λοιμώξεις η μελέτη επιχειρεί να προσδιορίσει την αποτελεσματικότητα του ΑPOTEL Μax® έναντι εικονικού φαρμάκου για την αντιμετώπιση του πυρετού σε ασθενείς με λοιμώξεις.
    E.2.2Secondary objectives of the trial
    Pharmacokinetics of paracetamol
    Φαρμακοκινητική της παρακεταμόλης
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ALL following criteria should be met for the inclusion of a patient in the study:
    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 38.5degC
    6.Infection of the upper respiratory tract, of the lower respiratory tract, acute pyelonephritis or infection of the skin and soft tissues that can explain fever onset
    Για την εισαγωγή των ασθενών στη μελέτη θα πρέπει να πληρούνται ΟΛΕΣ οι πιο κάτω προϋποθέσεις:
    1.Έγγραφη συγκατάθεση από τους ασθενείς
    2.Ασθενείς και των δύο φύλων
    3.Ηλικία μεγαλύτερη ή ίση των 18 ετών
    4.Έναρξη πυρετού εντός λιγότερο από 24 ώρες.
    5.Θερμοκρασία σώματος μεγαλύτερη ή ίση με 38.5degC
    6.Λοίμωξη του ανώτερου αναπνευστικού συστήματος, του κατώτερου αναπνευστικού συστήματος, του ανώτερου ουροποιητικού συστήματος ή δέρματος/μαλακών μορίων στην οποία μπορεί να αποδοθεί ο πυρετός του ασθενούς
    E.4Principal exclusion criteria
    Patients who meet any of the below exclusion criteria cannot be enrolled in the study:
    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
    Από τη μελέτη αποκλείονται όσοι ασθενείς πληρούν τουλάχιστον ένα από τα ακόλουθα κριτήρια:
    1.Ηλικία μικρότερη από 18 έτη
    2.Απουσία έγγραφης συγκατάθεσης
    3.Λήψη παρακεταμόλης από του στόματος ή ενδοφλέβια ή ενδομυϊκά για τον οποιοδήποτε λόγο στη διάρκεια των τελευταίων 12 ωρών
    4.Λήψη οποιοδήποτε άλλου μη στεροειδούς αντιφλεγμονώδους φαρμάκου στη διάρκεια των τελευταίων 8 ωρών
    5.Λήψη οποιοδήποτε στεροειδούς αντιφλεγμονώδους φαρμάκου στη διάρκεια των τελευταίων 12 ωρών
    6.Ιστορικό κίρρωσης του ήπατος
    7.Τιμή κρεατινίνης αίματος μεγαλύτερη από 3 mg/dl
    8.Τιμή ασπαραγινικής αμινοτρανσφεράσης αίματος μεγαλύτερη από 3 φορές από την ανώτερη φυσιολογική για το εργαστήριο του οικείου νοσοκομείου
    9.Ιστορικό αλλεργίας σε μη στεροειδή αντιφλεγμονώδη φάρμακα ή στην παρακεταμόλη
    10.Κύηση ή γαλουχία
    11.Ενεργός αιμορραγία του ανώτερου ή του κατώτερου πεπτικού συστήματος
    12.Θρομβοπενία ορισθείσα ως <50000 αιμοπετάλια κκχ
    E.5 End points
    E.5.1Primary end point(s)
    The comparative efficacy of intravenously administered ΑPOTEL Μax® over placebo for the achievement of defervescence; deferevescence is defined as any body temperature equal to or lower than 37.1 degC.
    Η σύγκριση της αποτελεσματικότητας του ενδοφλεβίως χορηγούμενου σκευάσματος ΑPOTEL Μax® με εικονικό φάρμακο στην επίτευξη απυρεξίας. Για τις ανάγκες του πρωτοκόλλου ορίζεται ως απυρεξία θερμοκρασία σώματος μικρότερη ή ίση με 37.1 degC.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 and 6 hours
    3 και 6 ώρες
    E.5.2Secondary end point(s)
    •The comparison between the two study groups on the frequency and time to administration of rescue drug
    •The correlation between defervescence with the rescue drug with the efficacy of the initially administered type of study drug (placebo over active drug)
    •The correlation between the achievement of defervescence and the concentrations of free active paracetamol and its metabolites in the serum of the patients
    •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
    •Η σύγκριση των ομάδων μελέτης ως προς τη συχνότητα και το χρόνο χορήγησης φαρμάκου διάσωσης
    •Η συσχέτιση επίτευξης απυρεξίας με το φάρμακο διάσωσης με την αποτελεσματικότητα του αρχικού φαρμάκου μελέτης (εικονικό φάρμακο/δραστικό φάρμακο)
    •Η συσχέτιση επίτευξης απυρεξίας με το φάρμακο μελέτης με τις συγκεντρώσεις δραστικής παρακεταμόλης και μεταβολιτών στον ορό των ασθενών
    •Η συσχέτιση επίτευξης απυρεξίας με το φάρμακο διάσωσης με τη χορήγηση άλλων αντιπυρετικών κατά τη γνώμη των θεραπόντων ιατρών
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 hours
    30 ώρες
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    When 80 patients are enrolled
    Με την εισαγωγή 80 ασθενών
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2014-08-20. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Every patient is allowed, if he/she asks, to receive one dose of the active drug (ΑPOTEL Μax®) three hours after the start of the study drug as rescue medication. The investigators are obliged to administer one dose of ΑPOTEL Μax® as rescue medication if body temperature returns to more than or equal to 38.5 degC within 6 to 24 hours from the start of the study drug, provided that the patients was not given any other dose of this rescue medication.
    Κάθε ασθενής έχει δικαίωμα, εφόσον το ζητήσει, να λάβει μία δόση της δραστικής ουσίας (ΑPOTEL Μax®) μετά το πέρας 3 τριών ωρών από την έναρξη του φαρμάκου μελέτης ως φάρμακο διάσωσης. Μία δόση της δραστικής ουσίας ΑPOTEL Μax® πρέπει να χορηγηθεί από τους ερευνητές ως φάρμακο διάσωσης εφόσον η θερμοκρασία σώματος υπερβεί ή είναι ίση με 38.5 C μέσα σε χρονικό διάστημα 6 ως 24 ώρες από την έναρξη του φαρμάκου μελέτης και υπό την προϋπόθεση ότι δεν έχει ήδη χορηγηθεί δόση του φαρμάκου διάσωσης.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-03-19
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