Subcutaneous route and pharmacology of metoclopramide - SOPHA-Méto

Phase 1

• Conditions: Digestive disorder (Nausea and vomiting) in palliative care and oncology; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2014-004282-25-FR
• Lead Sponsor: CHU de Bordeaux

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-25
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 24

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Clarify subcutaneous absorption of metoclopramide;<br> Secondary Objective: Specify the SC absorption of metoclopramide for each dose of the study (10, 20 and 40 mg / d)<br> Evolution relationship of the dose-bioavailability for the SC route<br> Comparison of plasma dose-concentration metoclopramide by SC and IV through their apparent clearances<br> Check local tolerance of the injectable metoclopramide for IV and SC administration<br> Compare the clinical effect of metoclopramide in SC and IV route.<br> ;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