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Search / Trial NCT02283203

A New Formulation of Intravenous Paracetamol for Fever Management

Launched by UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A. · Oct 31, 2014

Trial Information

Current as of August 11, 2025

Completed

Keywords

Paracetamol Management Of Fever Infections

ClinConnect Summary

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 significantl...

Gender

ALL

Eligibility criteria

  • 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.

About Uni Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.

Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A. is a leading pharmaceutical company based in Greece, dedicated to the development and manufacturing of innovative healthcare solutions. With a strong emphasis on research and development, the company specializes in a diverse range of therapeutic areas, including prescription medications, over-the-counter products, and dietary supplements. Committed to enhancing patient outcomes, Uni-Pharma adheres to stringent quality standards and regulatory compliance, ensuring that its clinical trials are conducted with the highest levels of integrity and scientific rigor. Through collaboration with healthcare professionals and institutions, Uni-Pharma strives to bring advanced therapeutic options to market that address unmet medical needs.

Locations

Chalkida, , Greece

Thessaloniki, , Greece

Haidari/Athens, , Greece

Herakleion, , Greece

Magoula Attikis, , Greece

Rion/Patras, , Greece

Patients applied

0 patients applied

Trial Officials

Dimitrios Boumpas, MD, PhD

Principal Investigator

Attikon Hospital

Charalambos Gogos, MD, PhD

Principal Investigator

University Hospital of Patras

George Samonis, MD, PhD

Principal Investigator

University Hospital of Crete

Styliani Sympardi, MD

Principal Investigator

Thriasio General Hospital of Elefsina

Asterios Karagiannis, MD, PhD

Principal Investigator

University Hospital of Thessaloniki Hippokrateion

Nikolaos Tsokos, MD

Principal Investigator

General Hospital of Halkida

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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