AN OPEN-LABEL, NON-RANDOMIZED PHASE IV CLINICAL TRIAL OF THE EFFICACY OF INTRAVENOUSLY ADMINISTERED 1000MG PARACETAMOL AS ANTIPYRETIC AND ANALGESIC MEDICATION - ?NTRAVENOUS 1000MG PARACETAMOL AS ANTIPYRETIC AND ANALGESIC MEDICATIO

• Conditions: Fever and pain; MedDRA version: 9.1Level: LLTClassification code 10010264Term: Condition aggravated

• Registration Number: EUCTR2008-004807-67-GR
• Lead Sponsor: niversity of Athens, Medical School

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•?ge 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-iinflammatory 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified