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
Overview
- Phase
- Phase 4
- Intervention
- APOTEL max
- Conditions
- Fever
- Sponsor
- Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
- Enrollment
- 80
- Locations
- 6
- Primary Endpoint
- Body temperature as a measure of to compare the efficacy of intravenously administered ΑPOTEL Μax® over placebo for the achievement of defervescence.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written informed consent by the patient
- •Patient of either gender
- •Age equal to or greater than 18 years old
- •Fever onset less than 24 hours
- •Body temperature greater than or equal to 38.50C.
- •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
- •Age below 18 years old
- •Denial for written consent
- •Intake of paracetamol for any reason either orally or intravenously or intramuscularly the last 12 hours
- •Intake of any non-steroidal anti-inflammatory drug the last 8 hours
- •Intake of any steroidal anti-inflammatory drug the last 12 hours
- •History of liver cirrhosis
- •Serum creatinine greater than 3 mg/dl
- •Aspartate aminotransferase more than 3 times greater than the upper normal limit for the hospital lab
- •Known allergy to non-steroidal anti-inflammatory drugs or to paracetamol
- •Pregnancy or lactation
Arms & Interventions
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: APOTEL max
Placebo
Placebo; water for injection at a volume of 100ml with added inactive ingredients, infused within 15 minutes. Available in 100ml bags.
Intervention: Placebo
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Need for the administration of rescue drug.(30 hours)
- Correlation between serum concentrations of free active paracetamol and metabolites with the clinical efficacy of paracetamol(30 hours)
- Comparison of defervescence with the rescue drug in the paracetamol arm with the placebo arm(30 hours)
- The administration of other antipyretics by the attending physicians after rescue drug in each study group(30 hours)