Pilot study of the pharmacokinetic profile of subcutaneous versus intravenous paracetamol in palliative patients

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Caen Normandie

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Not possible to specify

Decision date (initial)

2024-10-28

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

CHU CAEN Normandie

External identifiers

EU CT number

2024-518795-31-00

EudraCT number

2018-000080-85

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacokinetic, Safety

Determine the pharmacokinetic profile of subcutaneous Paracetamol in palliative care patients and compare it to the intravenous pharmacokinetic profile in the same patients

Secondary objectives 3

1. Effectiveness in pain control
2. olerance of the route of administration: skin monitoring (change in color, appearance of edema, skin necrosis, allergic reaction) and monitoring of the appearance of pain at the puncture site by an EN
3. Overall tolerance

Conditions and MedDRA coding

Adult patients (> 18 years of age) undergoing palliative care (defined by the WHO as active, comprehensive care given to patients whose condition does not respond to curative treatment) of their disease, able to communicate, and with a functional central venous line with reflux, presenting spontaneous pain with a numerical scale greater than 3 or paracetamol as part of their usual treatment.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. - Hospitalized patient (18 years or older) with a pathology under palliative care (defined by the WHO as active, comprehensive care given to patients whose condition does not respond to curative treatment)- Hospitalized patient (18 years or older) with a pathology under palliative care (defined by the WHO as active, comprehensive care given to patients whose condition does not respond to curative treatment).
2. - With a functional central IV line with reflux (implantable venous site, picc-line, central line)
3. - Presenting spontaneous pain, not related to care, with a numerical scale (EN) greater than 3/10 or having a prescription for paracetamol as part of their usual treatment
4. - Patient able to self-assess pain with an EN
5. - No contraindication to paracetamol
6. - No contraindication to the administration of alternative analgesics (weak opioids, strong opioids, NSAIDs) during the protocol and washout periods.
7. - No medical contraindication to the suspension of Paracetamol in the 24 hours preceding the first study administration (e.g. absence of fever).
8. - Have a blood test less than 7 days old, showing no end-stage liver or kidney disease contraindicating paracetamol administration
9. - Patient agreement to take part in study, informed consent signature collected
10. - The need to be affiliated to the social security system

Exclusion criteria 13

1. - Patient under 18 years of age
2. - Patient under legal protection
3. - Patient participating in another research protocol or having participated in another protocol within less than 30 days
4. - Patients with contraindications to paracetamol
5. - Weights under 50 kg
6. - Patient is not palliative (as defined by the WHO) for his disease
7. - Patients with contraindications to subcutaneous treatment (infection or edema at puncture site)
8. - Pregnant or breast-feeding women
9. - Patient having received paracetamol within 24 hours prior to the first paracetamol administration in the study
10. - Patient having received a Weak opioid (immediate-release tramadol) within 2 hours or a Strong opioid (immediate-release morphine or oxycodone, injectable or oral, injectable or transmucosal fentanyl) within one hour prior to administration of paracetamol (as part of tolerance monitoring).
11. - Patient with fever
12. - No functional venous line
13. - No communication possible

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. - Measurement of paracetamolemia to determine AUC0-t, AUC0-, Cmax , Vd and t1/2 for each mode of administration for the same patient, and generation of pharmacokinetic curves.

Secondary endpoints 3

1. - Pain assessment using a digital scale
2. - Skin monitoring and tolerance assessment throughout administration and protocol completion (D0 to D30)
3. - Safety criterion: systematic collection of adverse events of any grade (CTCAE scale) from the signing of consent to D30 (minimum follow-up period for drug research).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Caen Normandie

Sponsor organisation

Centre Hospitalier Universitaire De Caen Normandie

Address

Avenue De La Cote De Nacre, Cs 30001 Cs 30001

City

Caen Cedex 9

Postcode

14033

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Caen Normandie

Contact name

Investigateur Coordinateur

Public contact point

Organisation

Centre Hospitalier Universitaire De Caen Normandie

Contact name

Investigateur Coordinateur

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications