MedDataX Logo

Pharmacokinetic Study of Paracetamol in Patients Over 80 Years Hospitalized to an Acute Geriatric Ward

NCT ID: NCT03617471

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2020-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this exploratory study is the characterization of the pharmacokinetic (PK) profile of paracetamol in older patients and the specific PK (pharmacokinetic) variables associated with plasma exposure in this population.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The goal of this exploratory study is the characterization of the pharmacokinetic profile of paracetamol in older patients and the specific PK variables associated with plasma exposure in this population. The primary endpoint is the identification of the pharmacokinetic parameters: area under the curve (AUC), peak plasma concentration after administration of paracetamol (Cmax) and the time at which the Cmax is observed (Tmax) of paracetamol. The secondary endpoint consists of 3 sub-endpoints:

1. The variability in plasma exposure: volume of distribution (Vd), clearance (Cl) and elimination half-life (t1/2)
2. The association between the PK parameters and pathophysiological factors
3. The correlation between PK parameters and clinical parameters.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Paracetamol oral tablets 1g tid

Patients received paracetamol one gram three times daily. Venopuncture for PK profiling

Group Type EXPERIMENTAL

Venopuncture for PK profiling

Intervention Type PROCEDURE

Blood samples at T0, T0.5, T1, T2, T4, T6

Paracetamol oral granules 1g tid

Patients received paracetamol one gram three times daily. Venopuncture for PK profiling

Group Type EXPERIMENTAL

Venopuncture for PK profiling

Intervention Type PROCEDURE

Blood samples at T0, T0.5, T1, T2, T4, T6

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Venopuncture for PK profiling

Blood samples at T0, T0.5, T1, T2, T4, T6

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Blood sampling for paracetamol dosage

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* a minimum age of 80 years
* admission to the acute geriatrics ward
* oral intake of paracetamol 1000 milligram (mg) in tablet form tid
* a steady state situation (defined as at least 4 consecutive intakes of paracetamol before sampling)

Exclusion Criteria

* palliative care setting with downgrading of care
Minimum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

KU Leuven

OTHER

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Isabelle Spriet

PharmD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Isabel Spriet, PharmD PhD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universitaire Ziekenhuizen Leuven

Leuven, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

S58396 - mp05485

Identifier Type: -

Identifier Source: org_study_id