PainNCT03617471
Pharmacokinetic Study of Paracetamol in Patients Over 80 Years Hospitalized to an Acute Geriatric Ward
A study testing Venopuncture for PK profiling in people with Pain, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Venopuncture for PK profiling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2015to Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- palliative care setting with downgrading of care
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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:
- The variability in plasma exposure: volume of distribution (Vd), clearance (Cl) and elimination half-life (t1/2)
- The association between the PK parameters and pathophysiological factors
- The correlation between PK parameters and clinical parameters.
- Conditions
- Pain
- Being tested
- Venopuncture for PK profiling
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venopuncture for PK profilingProcedure or surgery
Also called Blood sampling for paracetamol dosage
Blood samples at T0, T0.5, T1, T2, T4, T6
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol oral tablets 1g tid | Experimental | Patients received paracetamol one gram three times daily. Venopuncture for PK profiling Receives: Procedure: Venopuncture for PK profiling |
| Paracetamol oral granules 1g tid | Experimental | Patients received paracetamol one gram three times daily. Venopuncture for PK profiling Receives: Procedure: Venopuncture for PK profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of the pharmacokinetic parameters: AUC
Area under the curve (AUC)
Measured: 8 hours (= during 1 dosing interval at steady state)
Identification of the pharmacokinetic parameters: Cmax
Peak plasma concentration after administration of paracetamol (Cmax)
Measured: 8 hours (= during 1 dosing interval at steady state)
Identification of the pharmacokinetic parameters: Tmax
The time at which the Cmax is observed (Tmax) of paracetamol
Measured: 8 hours (= during 1 dosing interval at steady state)
Secondary outcomes (6)
Variability in plasma exposure: Vd
Volume of distribution (Vd)
Measured: 8 hours (= during 1 dosing interval at steady state)
Variability in plasma exposure: t1/2
Elimination half-life (t1/2)
Measured: 8 hours (= during 1 dosing interval at steady state)
Variability in plasma exposure: Cl
Clearance (Cl)
Measured: 8 hours (= during 1 dosing interval at steady state)
The association between the AUC (area under the curve) of paracetamol and patient related factors.
Multivariate analysis will be performed with AUC (area under the curve) as outcome. This will allow to identify variables influencing AUC of paracetamol. Patient related factors include amongst others age, weight, albumin, bilirubin, serum creatinin and co medication.
Measured: 8 hours (= during 1 dosing interval at steady state)
The association between the AUC (area under the curve) of paracetamol and pain scores.
Pain scores will be based on the Numeric Rating Scale with a score of 0 indicating no pain and a score of 10 indicating worst imaginable pain.
Measured: 8 hours (= during 1 dosing interval at steady state)
Correlation between immuno assay method and the Liquid chromatography-tandem mass spectrometry (LC-MS/MS) method to determine paracetamol concentrations in serum
Correlation between two different assays will be determined through Bland Altman statistics.
Measured: 8 hours (= during 1 dosing interval at steady state)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study startNov 2015
- Primary completionJan 2016
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Principal investigator, Isabelle Spriet, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Isabel Spriet, PharmD PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03617471
- Sponsor's protocol ID
- S58396 - mp05485
- Status last verified
- Nov 2023
- First submitted
- 29 Nov 2016
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of Paracetamol in Patients Over 80 Years Hospitalized to an Acute Geriatric Ward
- ClinicalTrials.gov ID
- NCT03617471
- Acronym / sponsor ID
- S58396 - mp05485
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- Nov 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 6 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- The variability in plasma exposure: volume of distribution (Vd), clearance (Cl) and elimination half-life (t1/2)
- The association between the PK parameters and pathophysiological factors
- The correlation between PK parameters and clinical parameters.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paracetamol oral tablets 1g tid | Experimental | Procedure: Venopuncture for PK profilingPatients received paracetamol one gram three times daily. Venopuncture for PK profiling |
| Paracetamol oral granules 1g tid | Experimental | Procedure: Venopuncture for PK profilingPatients received paracetamol one gram three times daily. Venopuncture for PK profiling |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- palliative care setting with downgrading of care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venopuncture for PK profilingAlso: Blood sampling for paracetamol dosageBlood samples at T0, T0.5, T1, T2, T4, T6 | Procedure or surgery | Paracetamol oral granules 1g tid, Paracetamol oral tablets 1g tid |
Primary outcome
Identification of the pharmacokinetic parameters: AUC
Time frame: 8 hours (= during 1 dosing interval at steady state)
Area under the curve (AUC)
Identification of the pharmacokinetic parameters: Cmax
Time frame: 8 hours (= during 1 dosing interval at steady state)
Peak plasma concentration after administration of paracetamol (Cmax)
Identification of the pharmacokinetic parameters: Tmax
Time frame: 8 hours (= during 1 dosing interval at steady state)
The time at which the Cmax is observed (Tmax) of paracetamol
6 secondary outcomes
Variability in plasma exposure: Vd
Time frame: 8 hours (= during 1 dosing interval at steady state)
Variability in plasma exposure: t1/2
Time frame: 8 hours (= during 1 dosing interval at steady state)
Variability in plasma exposure: Cl
Time frame: 8 hours (= during 1 dosing interval at steady state)
The association between the AUC (area under the curve) of paracetamol and patient related factors.
Time frame: 8 hours (= during 1 dosing interval at steady state)
The association between the AUC (area under the curve) of paracetamol and pain scores.
Time frame: 8 hours (= during 1 dosing interval at steady state)
Correlation between immuno assay method and the Liquid chromatography-tandem mass spectrometry (LC-MS/MS) method to determine paracetamol concentrations in serum
Time frame: 8 hours (= during 1 dosing interval at steady state)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabel Spriet, PharmD PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venopuncture for PK profiling in people with Pain, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of the pharmacokinetic parameters: AUC (time frame: 8 hours (= during 1 dosing interval at steady state)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.