Paracetamol as Antipyretic and Analgesic Medication (APOTEL01)

This study has been completed.
Sponsor:
Information provided by:
University of Athens
ClinicalTrials.gov Identifier:
NCT01070732
First received: February 17, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

The present study is aiming to unravel the clinical efficacy of intravenously administered paracetamol as antipyretic and analgesic medication in various medical conditions.


Condition Intervention Phase
Fever
Analgesia
Drug: Paracetamol
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: An Open-label Non-randomized Phase IV Trial of the Clinical Efficacy of Intravenously Administered 1000mg Paracetamol as Antipyretic and Analgesic Medication

Resource links provided by NLM:


Further study details as provided by University of Athens:

Primary Outcome Measures:
  • To evaluate the safety and efficacy of intravenously administered 1000mg ΑPOTEL® as antipyretic and analgesic medication. [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics of paracetamol after intravenous infusion. [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Effect of paracetamol after intravenous infusion in serum inflammatory mediators [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: January 2010
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paracetamol
All patients will receive one single dose of 1000mg paracetamol.
Drug: Paracetamol
All patients will receive one single dose of 1000mg paracetamol. If considered mandatory by the attending physician, similar doses may be administered latter for a maximum period of five days. The maximum allowed daily dose is 3000mg. If the attending physician believes that after the administration of at least of three doses the desired analgesic or antipyretic effect is not achieved, he may administer any other compound in his will.
Other Name: ΑPOTEL®

Detailed Description:

Although modern therapeutics is targeting at prolongation of survival, despite the underlying illness, it also aims at the improvement of the quality of life. Two major symptoms affect considerably quality of life, fever and pain. Both symptoms are common denominators of a vast number of clinical situations some of which have good prognosis and some of which do not have. Among them situations like infectious diseases, hematologic malignancies, solid tumor malignancies, connective tissue disorders and factors connected to surgical operations predominate. Post-operative pain extents too long and imposes severely on the post-operative course of the patient.

A variety of compounds have been developed for the management of fever and pain, the most successful being non-steroidal anti-inflammatory drugs. They exist in a variety of forms for various types of administration. Those administered parenterally are considered more efficacious than those administered orally in terms of the rate of the achieved clinical effect. Furthermore, several conditions necessitate parenteral administration.

Paracetamol is a well-known antipyretic and analgesic compound available for many years for oral administration since intravenous infusion was hampered by water insolubility. Its pro-drug, namely, pro-paracetamol, was applied for intravenous infusion where an amount of 2g was equally potent to 1 g of paracetamol. Pro-paracetamol has been given with success as analgesic medication in women undergoing laparoscopic operation, as antipyretic in patients with hematologic malignancies, as antipyretic in children bearing infectious diseases and as antipyretic in critically ill patients.

Ready-made paracetamol for intravenous infusion has been in the market in some European countries. It has been tested in four clinical trials. In the first trial it was given as post-operative analgesia at a dose of 1g x 4 in 80 patients undergoing laparoscopic cholecystectomy. Clinical efficacy was comparable to parecoxib and valdecoxib. In three other studies, it was given as post-operative analgesia after spinal body ectomy and after resection of the third mole providing conflicting results. However, in all the three latter studies, the number of patients given paracetamol was limited.

In Greece, paracetamol for intravenous infusion at vials of 1g/6.7ml is manufactured by the company Uni-Pharma (ΑPOTEL®). Based on: a) the limited number of patients enrolled in the studies mentioned earlier, and b) the application of that form only after laparoscopic cholecystectomy and spinal body ectomy, the present study is aiming to unravel the clinical efficacy of the above formula of 1g intravenous paracetamol as antipyretic and analgesic medication in various medical conditions.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age greater than or equal to 18 years
  • Written informed consent by the patients
  • Medical condition necessitating the administration of antipyretic or analgesic medications

Exclusion Criteria:

  • Αge lower than 18 years
  • Lack of informed consent
  • History of liver cirrhosis
  • Blood creatinine greater than 3mg/dl
  • Blood AST greater than 3 times the upper normal level according to the lab of the participating hospital
  • History of hypersensitivity to non-steroidal ant-inflammatory drugs
  • History of abuse of analgesics
  • Pregnancy or lactation
  • Fulminant hemorrhage of the upper or lower digestive tract
  • Thrombocytopenia defined as less than 50000 platelets/μl
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01070732

Locations
Greece
4th Department of Internal Medicine, ATTIKON University Hospital
Athens, Greece, 12462
2nd Department of Medicine, Sismanogleion General Hospital
Athens, Greece, 15526
2nd Department of Surgery, G. Gennimatas General Hospital
Thessaloniki, Greece
Sponsors and Collaborators
University of Athens
Investigators
Study Chair: Evangelos J Giamarellos-Bourboulis, MD, PhD University of Athens, Medical School
Principal Investigator: Helen Giamarellou, MD, PhD ATTIKON University Hospital of Athens
Principal Investigator: George Koratzanis, MD, PhD Sismanogelion General Hospital, Athens
Principal Investigator: Konstantinos Atmatzidis, MD, PhD G.Gennimatas General Hospital of Thessaloniki
  More Information

Publications:
Responsible Party: Evangelos Giamarellos-Bourboulis, Assistant Professor of Medicine, University of Athens, Medical School
ClinicalTrials.gov Identifier: NCT01070732     History of Changes
Other Study ID Numbers: APOTEL01
Study First Received: February 17, 2010
Last Updated: February 17, 2010
Health Authority: Greece: Ethics Committee
Greece: National Organization of Medicines

Keywords provided by University of Athens:
Fever
Infectious diseases
Neoplasia
Pain
cholecystectomy
Colectomy

Additional relevant MeSH terms:
Fever
Body Temperature Changes
Signs and Symptoms
Acetaminophen
Antipyretics
Analgesics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014