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Pilot study of the pharmacokinetic profile of paracetamol subcutaneously versus intravenously in patients in a palliative situation

Status
Not yet recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518795-31-00
Acronym
17-245
Enrollment
12
Registered
2024-10-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-22

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

Conditions

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

Brief summary

- 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.

Detailed description

- Pain assessment using a digital scale, - Skin monitoring and tolerance assessment throughout administration and protocol completion (D0 to D30), - 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).

Interventions

DRUGsolution pour perfusion

Sponsors

Centre Hospitalier Universitaire De Caen Normandie
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
- 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

MeasureTime frame
- Pain assessment using a digital scale, - Skin monitoring and tolerance assessment throughout administration and protocol completion (D0 to D30), - 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).

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026