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Paracetamol as Antipyretic and Analgesic Medication (APOTEL01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01070732
Recruitment Status : Completed
First Posted : February 18, 2010
Last Update Posted : February 18, 2010
Information provided by:
University of Athens

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

Condition or disease Intervention/treatment Phase
Fever Analgesia Drug: Paracetamol Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2010
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Arm Intervention/treatment
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®

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

Secondary Outcome Measures :
  1. Pharmacokinetics of paracetamol after intravenous infusion. [ Time Frame: One year ]
  2. Effect of paracetamol after intravenous infusion in serum inflammatory mediators [ Time Frame: One year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01070732

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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
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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
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Responsible Party: Evangelos Giamarellos-Bourboulis, Assistant Professor of Medicine, University of Athens, Medical School Identifier: NCT01070732    
Other Study ID Numbers: APOTEL01
First Posted: February 18, 2010    Key Record Dates
Last Update Posted: February 18, 2010
Last Verified: February 2010
Keywords provided by University of Athens:
Infectious diseases
Additional relevant MeSH terms:
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Body Temperature Changes
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs