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
|Condition or disease||Intervention/treatment||Phase|
|Fever||Drug: APOTEL max Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||February 2015|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
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 Name: 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.
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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02283203
|General Hospital of Chalkida|
|Chalkida, Greece, 34100|
|Haidari/Athens, Greece, 12462|
|University Hospital of Crete|
|Herakleion, Greece, 71110|
|Thriasion Elefsis General Hospital|
|Magoula Attikis, Greece, 19018|
|University Hospital of Patras|
|Rion/Patras, Greece, 26504|
|General Hospital Of Thessaloniki Ippokratio|
|Thessaloniki, Greece, 54642|
|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|