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A New Formulation of Intravenous Paracetamol for Fever Management

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ClinicalTrials.gov Identifier: NCT02283203
Recruitment Status : Completed
First Posted : November 5, 2014
Last Update Posted : March 22, 2016
Sponsor:
Collaborators:
Attikon Hospital
University Hospital of Patras
University Hospital of Crete
Thriasion Elefsis General Hospital
General Hospital Of Thessaloniki Ippokratio
General Hospital of Chalkida
Information provided by (Responsible Party):
Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.

Tracking Information
First Submitted Date  ICMJE October 19, 2014
First Posted Date  ICMJE November 5, 2014
Last Update Posted Date March 22, 2016
Study Start Date  ICMJE February 2015
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02283203 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2014)
  • 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.
  • 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).
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A New Formulation of Intravenous Paracetamol for Fever Management
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Fever
Intervention  ICMJE
  • 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 Name: Paracetamol solution for infusion, 1gram per 100ml bag
  • 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 Name: Water for injection and vehicles
Study Arms  ICMJE
  • 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.
    Intervention: Drug: APOTEL max
  • Placebo Comparator: Placebo
    Placebo; water for injection at a volume of 100ml with added inactive ingredients, infused within 15 minutes. Available in 100ml bags.
    Intervention: Drug: Placebo
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. Epub 2014 Jan 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 31, 2014)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02283203
Other Study ID Numbers  ICMJE APOTEL-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
Study Sponsor  ICMJE Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
Collaborators  ICMJE
  • Attikon Hospital
  • University Hospital of Patras
  • University Hospital of Crete
  • Thriasion Elefsis General Hospital
  • General Hospital Of Thessaloniki Ippokratio
  • General Hospital of Chalkida
Investigators  ICMJE
Principal Investigator: 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 Thriasion Elefsis General Hospital
Principal Investigator: Asterios Karagiannis, MD, PhD University Hospital of Thessaloniki Hippokrateion
Principal Investigator: Nikolaos Tsokos, MD General Hospital of Halkida
PRS Account Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP