NCT02466984

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2016

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 9, 2015

Completed
1.1 years until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2019

Completed
Last Updated

May 12, 2026

Status Verified

March 1, 2019

Enrollment Period

1.6 years

First QC Date

May 29, 2015

Last Update Submit

May 11, 2026

Conditions

NauseaVomiting

Keywords

metoclopramidesubcutaneous routepalliative carepharmacologybioavailabilitynauseavomiting

Outcome Measures

Primary Outcomes (1)

  • Absolute bioavailability of SubCutaneus administration metoclopramide

    Calculated by the average ratio of plasma concentrations between SC route and IV on all doses of the study (10, 20 and 30 mg / d)

    13 days

Secondary Outcomes (6)

  • Absolute bioavailability of metoclopramide subcutaneously at each dose of the study (10, 20 and 30 mg / d)

    13 days

  • Dose-bioavailability of metoclopramide for the SC route

    13 days

  • Relations plasma concentration-dose metoclopramide subcutaneously and intravenously

    13 days

  • Cutaneous inflammatory signs and subcutaneous at the puncture site

    During 13 days

  • Numeric scale ranging from 0 to 10 for nausea

    During 13 days

  • +1 more secondary outcomes

Study Arms (2)

metoclopramide subcutaneous

EXPERIMENTAL

every two days, first from 10 to 20 and then from 20 to 30 mg/d

Drug: metoclopramide intravenous

metoclopramide intravenous

ACTIVE COMPARATOR

first from 10 to 20 and then from 20 to 30 mg/d

Drug: metoclopramide intravenous

Interventions

metoclopramide intravenousDRUG

Administration route

Also known as: Primperan
metoclopramide intravenousmetoclopramide subcutaneous

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 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

You may not qualify if:

  • Pregnant or breastfeeding women
  • Current Treatment for severe and progressive threatening disease
  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Bordeaux - St André

Bordeaux, Aquitaine, 33000, France

Location

MeSH Terms

Conditions

NauseaVomiting

Interventions

Metoclopramide

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic Chemicalspara-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsChlorobenzoatesHydroxybenzoate EthersHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenyl EthersPhenols

Study Officials

  • Matthieu FRASCA, MD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2015

First Posted

June 9, 2015

Study Start

July 1, 2016

Primary Completion

February 8, 2018

Study Completion

February 8, 2019

Last Updated

May 12, 2026

Record last verified: 2019-03

Locations

FR(1)