Subcutaneous Route and Pharmacology of Metoclopramide

• Status: Completed
• Trial end date: 2019-02-08
• Target enrollment: 0
• Participant gender: All

Summary

Subcutaneous (SC) route has become a standard of care of many drugs administration in palliative medicine. A preliminary study showed that, although it was widely adopted among palliative care practitioners for routinely prescribed medications, standards of proof are still lacking for many molecules. Among them, metoclopramide is a largely employed drug for nausea and vomiting treatment, particularly in palliative care and oncology. Therefore, the investigator aim to study absorption and efficacy of subcutaneous administration of metoclopramide.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux
• Treatments: Metoclopramide

Criteria

Inclusion Criteria:

• Man or woman > 18 years

• Patients hospitalized at the palliative medical care unit of University Hospital Bordeaux

• Patient whose life expectancy is greater to 4 weeks

• Patients suffering from nausea the day of inclusion with a greater than or equal score to 3/10 on a numerical scale (FR) from 0 to 10 and / or have had at least one vomiting within three days prior to inclusion

• Patients may be infused through an IV and subcutaneous (SC)

• Patient can communicate verbally or in writing

• Patients affiliates or beneficiaries of a social security fund

• Patient has given his written consent

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

• Treatment with levodopa or dopamine agonists in progress

• Neuroleptic Processing

• Patient with lesion occlusive syndrome

• Patients at risk of gastrointestinal perforation

• Patient with clinical signs of gastrointestinal bleeding

• Parkinson's disease

• Patients with epilepsy not controlled by anti-seizure treatment

• Patients suffering from liver failure

• Patients with a heart rate less than 60 beats / min at baseline

• Patients with systolic blood pressure less than or equal to 90 mmHg at baseline

• History of allergy to metoclopramide

• History of allergy to ondansetron

• Previous history of tardive dyskinesia to neuroleptics or metoclopramide

• Previous history of pheochromocytoma

• Previous history of methemoglobinemia with metoclopramide

• History of deficit NADH-cytochrome b5 reductase

• Patient deprived of liberty by judicial or administrative decision

• Major protected by law

• Exclusion period Patient relative over another protocol.

Exclusion criteria

• Pregnant woman (blood β-HCG dosage ≥ 5 IU / L)

• Patients with a creatinine clearance less than or equal to 60 mL / min at baseline

• Patient with cardiac conduction disorders on ECG

• Patients with electrolyte imbalance in electrolytes