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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 MEDICATION

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 MEDICATION

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-004807-67-GR
Enrollment
Unknown
Registered
2009-02-18
Start date
2009-01-15
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fever and pain MedDRA version: 9.1 Level: LLT Classification code 10010264 Term: Condition aggravated

Interventions

Trade Name: APOTEL (paracetamol) Product Name: APOTEL® Product Code: 1854117 Pharmaceutical Form: Intravenous infusion INN or Proposed INN: Paracetamol Concentration unit: mg/g milligram(s)/gram Conce

Sponsors

University of Athens, Medical School
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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 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

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

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the efficacy of intravenously administered ?POTEL® as antipyretic and analgesic medication;Secondary Objective: Pharmacokinetics of intravenously administered ?POTEL® (paracetamol) Effect of ?POTEL® (paracetamol) on on inflammatory mediators;Primary end point(s): To evaluate the efficacy of intravenously administered 1000mg?POTEL® as antipyretic and analgesic medication—

Countries

Greece

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026