Digestive disorder (Nausea and vomiting) in palliative care and oncology
Conditions
Interventions
Trade Name: Primpéran
Product Name: Metoclopramide
Pharmaceutical Form: Solution for injection
Sponsors
CHU de Bordeaux
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Man or woman aged at least 18 years - Patient hospitalized at the University Hospital of Bordeaux on palliative department - Patients with life expectancy estimated by the investigator, is greater than 3 weeks - Patients suffering from nausea the day of inclusion with a score greater than or equal to 3/10 on a numerical scale and / or had at least one vomiting within three days prior to inclusion - Patient can be infused IV and SC - Patient can communicate verbally or in writing - Patient has given its written consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: - Pregnant or breastfeeding women - Current treatment for severe and progressive threatening disease - Treatment with oral or injectable metoclopramide within 3 days prior to inclusion - Current Treatment with levodopa or dopamine agonists - Neuroleptic Processing - Presence of clinical signs of encephalopathy (flapping, drowsiness, disorientation) - Patient achieved a lesion occlusive syndrome according to the investigator, - Patients at risk of gastrointestinal perforation according to the investigator - Patient with clinical signs of gastrointestinal bleeding - Patient with dyskinesia - Patient with an extra-pyramidal syndrome - Known or suspected patients with pheochromocytoma - History of allergy to metoclopramide - History of methemoglobinemia with metoclopramide - History deficit NADH-cytochrome b5 reductase- - Patient deprived of liberty by judicial or administrative decision - Major protected by law - Patient exclusion period relative over another protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Clarify subcutaneous absorption of metoclopramide; Secondary Objective: Specify the SC absorption of metoclopramide for each dose of the study (10, 20 and 40 mg / d) Evolution relationship of the dose-bioavailability for the SC route Comparison of plasma dose-concentration metoclopramide by SC and IV through their apparent clearances Check local tolerance of the injectable metoclopramide for IV and SC administration Compare the clinical effect of metoclopramide in SC and IV route. ;Primary end point(s): The primary endpoint of this study is the absolute bioavailability of SubCutaneous administration metoclopramide, calculated by the average ratio of plasma concentrations between Subcutaneous and IntraVenous route on all doses of the study (10, 20 and 40 mg / d).;Timepoint(s) of evaluation of this end point: Day 13 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The absolute bioavailability of metoclopramide subcutaneously at each dose of the study (10, 20 and 40 mg / d) calculated by the ratio of plasma concentrations between SC route and the IV route; - Dose-bioavailability of metoclopramide for the SC route; - The plasma concentration-dose relationship metoclopramide subcutaneously and intravenously measured through their apparent clearances (CL / F = D / T × 1 / Css), the creatinine clearance in patients is estimated to using the MDRD formula; - Cutaneous and subcutaneous inflammatory signs (heat, swelling, pain, redness) at the puncture site; - The effectiveness of metoclopramide on nausea and vomiting will be assessed at each dose level and for each route of administration by : *An numerical scale ranging from 0 to 10 for nausea; *The number of vomiting in the dose level; *The use of a setron during dose level. ;Timepoint(s) of evaluation of this end point: Day 13 | — |
Countries
France
Contacts
Public ContactResponsable of department
CHU de BORDEAUX
Outcome results
None listed