Clinical Trial Results:
Detection of paracetamol concentration in blood-, saline- and urine samples with an electrochemical indicator in healthy volunteers - a validation study for a novel technique.
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Summary
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EudraCT number |
2020-002908-39 |
Trial protocol |
FI |
Global end of trial date |
06 Oct 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
03 Dec 2023
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First version publication date |
03 Dec 2023
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Other versions |
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Summary report(s) |
Introduction of an electrochemical point-of-care assay for quantitative determination of paracetamol in finger-prick capillary whole blood samples |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
FEPODPara2020-1
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04690673 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Helsinki University Hospital
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Sponsor organisation address |
Stenbäckinkatu 9, Helsinki, Finland, 00290
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Public contact |
Johanna Kujala, Helsinki University Hospital, johanna.kujala@helsinki.fi
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Scientific contact |
Johanna Kujala, Helsinki University Hospital, johanna.kujala@helsinki.fi
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
13 Apr 2023
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
29 Apr 2022
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Global end of trial reached? |
Yes
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Global end of trial date |
06 Oct 2023
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The main objective was to assess whether a novel electrochemical tool is reliable in detecting concentration of paracetamol in fingerprick- , saline-, urine-, and serum samples.
We recruited 12 healthy volunteers, ages 18-45. They were delivered 1 g oral paracetamol. Paracetamol concentration was detected from abovementioned samples at timely intervals for 12 hours, analyzed with the novel electrochemical method and compared to gold standard mass-spectrometry analysis.
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Protection of trial subjects |
The trial included 12 volunteered adults, who were given one single dose of paracetamol 1 gram. This dose can be considered non-harmful.
Data of the subjects and their privacy was considered carefully during and after the trial.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Nov 2020
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Finland: 12
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Worldwide total number of subjects |
12
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EEA total number of subjects |
12
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
12
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
The subjects were recruited by announcements in the social media platforms for university students. 15 persons volunteered. 3 persons were excluded from the study due to contraindications (medication or tobacco use). 12 were recruited. | ||||||
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Pre-assignment
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Screening details |
Volunteers were recruited in accordance with the WMA Helsinki Declaration's ethical principles. For screening, medical history, laboratory tests including blood count, kidney and liver function and pregnancy tests for women, and physical examination were performed. | ||||||
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Period 1
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Period 1 title |
Pharmacokinetic measurements (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
This was a pharmacokinetic study, no blinding.
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Arms
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Arm title
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Pharmacokinetic study | ||||||
Arm description |
All volunteers were introduced to the pharmacokinetic study | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Paracetamol
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Investigational medicinal product code |
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Other name |
Acetaminophen
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
The volunteers entered the study premises after overnight fasting. A single dose of oral paracetamol 1 g was administered with 200 ml lukewarm water.
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Baseline characteristics reporting groups
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Reporting group title |
Pharmacokinetic measurements
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Reporting group description |
Twelve healthy subjects aged 18–28 years, nine male, three female, European origin, were recruited; BMIs were 21—28 kg/m2 (median 23); all completed. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Pharmacokinetic study
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Subject analysis set type |
Per protocol | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Volunteers ingested 1 g of paracetamol (Para-Tabs® 1 g, Orion Pharma, Finland) with 200 mL of water after overnight fasting. They had standardized meals four and eight hours after the paracetamol.
Paired finger-prick and venous blood samples were collected prior to paracetamol administration, followed by sampling at timepoints 0.5; 1.0; 1.5; 2.0; 3.0; 4.0; 6.0; 8.0 and 12 h.
Venous blood samples were centrifuged to plasma and frozen at -80°C for later HPLC-MS/MS analysis. Capillary finger-prick samples were collected for fast electrochemical POC analysis, and duplicate capillary blood samples with the VAMS Mitra® Cartridge Blood Sampling Device (Neoteryx, CA, USA) for later HPLC-MS/MS analysis.
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End points reporting groups
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Reporting group title |
Pharmacokinetic study
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Reporting group description |
All volunteers were introduced to the pharmacokinetic study | ||
Subject analysis set title |
Pharmacokinetic study
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Volunteers ingested 1 g of paracetamol (Para-Tabs® 1 g, Orion Pharma, Finland) with 200 mL of water after overnight fasting. They had standardized meals four and eight hours after the paracetamol.
Paired finger-prick and venous blood samples were collected prior to paracetamol administration, followed by sampling at timepoints 0.5; 1.0; 1.5; 2.0; 3.0; 4.0; 6.0; 8.0 and 12 h.
Venous blood samples were centrifuged to plasma and frozen at -80°C for later HPLC-MS/MS analysis. Capillary finger-prick samples were collected for fast electrochemical POC analysis, and duplicate capillary blood samples with the VAMS Mitra® Cartridge Blood Sampling Device (Neoteryx, CA, USA) for later HPLC-MS/MS analysis.
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End point title |
Cmax POC Capillary [1] | ||||||||
End point description |
Pharmacokinetic parameters of paracetamol from capillary whole blood samples with the novel electrochemical point-of-care (POC) method
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End point type |
Primary
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End point timeframe |
0- 12 hours.
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a concentration measurement. Data were presented as geometric means with geometric coefficients of variation as percentage. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Tmax POC Capillary [2] | ||||||||
End point description |
Pharmacokinetic parameters of paracetamol from capillary whole blood samples with the novel electrochemical point-of-care (POC) method
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End point type |
Primary
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End point timeframe |
0-12 h
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a concentration measurement. Data were presented as geometric means with geometric coefficients of variation as percentage. |
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| No statistical analyses for this end point | |||||||||
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End point title |
AUC 0-last POC Capillary [3] | ||||||||
End point description |
Pharmacokinetic parameters of paracetamol from capillary whole blood samples with the novel electrochemical point-of-care (POC) method
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End point type |
Primary
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End point timeframe |
0-12 h
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a concentration measurement. Data were presented as geometric means with geometric coefficients of variation as percentage. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Cmax HPLC-MS/MS venous plasma [4] | ||||||||
End point description |
Pharmacokinetic parameters of paracetamol from venous plasma samples measured with HPLC-MS/MS.
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End point type |
Primary
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End point timeframe |
0-12 h
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a concentration measurement. Data were presented as geometric means with geometric coefficients of variation as percentage. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Tmax HPLC-MS/MS venous plasma [5] | ||||||||
End point description |
Pharmacokinetic parameters of paracetamol from venous plasma samples measured with HPLC-MS/MS.
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End point type |
Primary
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End point timeframe |
0-12 h
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| Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a concentration measurement. Data were presented as geometric means with geometric coefficients of variation as percentage. |
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| No statistical analyses for this end point | |||||||||
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End point title |
AUC 0-last HPLC-MS/MS venous plasma [6] | ||||||||
End point description |
Pharmacokinetic parameters of paracetamol from venous plasma samples measured with HPLC-MS/MS.
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End point type |
Primary
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End point timeframe |
0-12 h
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| Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This is a concentration measurement. Data were presented as geometric means with geometric coefficients of variation as percentage. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Cmax HPLC-MS/MS capillary | ||||||||
End point description |
Pharmacokinetic parameters of paracetamol from capillary whole blood samples measured with HPLC-MS/MS.
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End point type |
Secondary
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End point timeframe |
0-12 h
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| No statistical analyses for this end point | |||||||||
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End point title |
Tmax HPLC-MS/MS capillary | ||||||||
End point description |
Pharmacokinetic parameters of paracetamol from capillary whole blood samples measured with HPLC-MS/MS.
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End point type |
Secondary
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End point timeframe |
0-12 h
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| No statistical analyses for this end point | |||||||||
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End point title |
AUC 0-last HPLC-MS/MS from capillary | ||||||||
End point description |
Pharmacokinetic parameters of paracetamol from capillary whole blood samples measured with HPLC-MS/MS.
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End point type |
Secondary
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End point timeframe |
0-12 h
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| No statistical analyses for this end point | |||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
24 h
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Adverse event reporting additional description |
The subjects received a standard 1g dose of paracetamol. The samples were collected within 12 hours from paracetamol intake. No adverse effects were reported.
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Assessment type |
Non-systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
26.1
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| Frequency threshold for reporting non-serious adverse events: 1% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: The volunteers were provided with 1 g of paracetamol with no adverse effects noticed from the drug. Venous and capillary blood samples were collected during 12 hours. No noticeable adverse effects occurred during sample collection. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/37218304 |
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