NauseaPhase 3SOPHA-MétoNCT02466984
Subcutaneous Route and Pharmacology of Metoclopramide
A Phase 3 study testing metoclopramide intravenous in people with Nausea and Vomiting, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- metoclopramide intravenous
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2016to 8 Feb 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Universitaire de Bordeaux - St André
Bordeaux, Aquitaine, 33000
About this study
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.
Read the detailed description
In this cross-over study, each patient receives subcutaneous and intravenous metoclopramide, with a randomized order of administration. During each perfusion phases, metoclopramide is administrated with continuous flow, doses being increased every two days, first from 10 to 20 and then from 20 to 30 mg/d. In order to guarantee plasmatic balance during route change, the first dose of the second phase is extended for three days. Metoclopramide plasmatic concentration is measured at inclusion and at the end of each dose administration, with a total of 7 dosages.
Principal purpose of this research is to clarify subcutaneous bioavailability of metoclopramide. For this meaning, the mean difference between all subcutaneous and intravenous concentration ratios is compared. Secondary purposes consist of: calculating metoclopramide subcutaneous bioavailability for each study dose (10, 20 and 30 mg/d); describing dose-bioavailability relation for subcutaneous metoclopramide; comparing dose-concentration relationship of intravenous and subcutaneous metoclopramide; studying local tolerance by checking all inflammatory signs surrounding injection site; evaluating clinical efficacy by comparing between the two groups the number of vomiting episodes, use of Serotonin receptor antagonists and the nausea scores on a 11-level numerical scale.
Eighteen patients have to be analysed at least. For each patient not having completed the study, one more will be included in order to reach the eighteen necessary patients. Therefore, it is expected to include twenty-four patients. Included population characteristics will be described. A three-dimensional analysis with period, subject and dose is performed to determine metoclopramide absolute bioavailability. For secondary criteria, dose-concentration relation is analysed with a four-dimensional analysis; dose-bioavailability and dose-concentration relations are described by linear and log-linear regression. For principal purpose, only results of patients having completed the study are part of this aforementioned analyse.
- Being tested
- metoclopramide intravenous
- Keywords
- metoclopramide, subcutaneous route, palliative care, pharmacology, bioavailability, nausea, vomiting
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metoclopramide intravenousDrug
Also called Primperan
Administration route
| Study group | Role | What they receive |
|---|---|---|
| metoclopramide subcutaneous | Experimental | every two days, first from 10 to 20 and then from 20 to 30 mg/d Receives: Drug: metoclopramide intravenous |
| metoclopramide intravenous | Active comparator | first from 10 to 20 and then from 20 to 30 mg/d Receives: Drug: metoclopramide intravenous |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 13 days
Secondary outcomes (6)
Absolute bioavailability of metoclopramide subcutaneously at each dose of the study (10, 20 and 30 mg / d)
Calculated by the ratio of plasma concentrations between SC route and the IV route;
Measured: 13 days
Dose-bioavailability of metoclopramide for the SC route
Measured: 13 days
Relations plasma concentration-dose metoclopramide subcutaneously and intravenously
Measured through their apparent clearances
Measured: 13 days
Cutaneous inflammatory signs and subcutaneous at the puncture site
Measured: During 13 days
Numeric scale ranging from 0 to 10 for nausea
Measured: During 13 days
Number of vomiting in the dose level;
Measured: During 13 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startJul 2016
- Primary completion8 Feb 2018
- Study completion8 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthieu FRASCA, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466984
- Sponsor's protocol ID
- CHUBX2014/10
- Other IDs
- 2014-004282-25, 2014
- Acronym
- SOPHA-Méto
- Status last verified
- Mar 2019
- First submitted
- 29 May 2015
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous Route and Pharmacology of Metoclopramide
- ClinicalTrials.gov ID
- NCT02466984
- Acronym / sponsor ID
- SOPHA-Méto / CHUBX2014/10
- Keywords
- metoclopramide, subcutaneous route, palliative care, pharmacology, bioavailability, nausea, vomiting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- 8 Feb 2018 (actual)
- Study completion
- 8 Feb 2019 (actual)
- First posted
- 9 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this cross-over study, each patient receives subcutaneous and intravenous metoclopramide, with a randomized order of administration. During each perfusion phases, metoclopramide is administrated with continuous flow, doses being increased every two days, first from 10 to 20 and then from 20 to 30 mg/d. In order to guarantee plasmatic balance during route change, the first dose of the second phase is extended for three days. Metoclopramide plasmatic concentration is measured at inclusion and at the end of each dose administration, with a total of 7 dosages.
Principal purpose of this research is to clarify subcutaneous bioavailability of metoclopramide. For this meaning, the mean difference between all subcutaneous and intravenous concentration ratios is compared. Secondary purposes consist of: calculating metoclopramide subcutaneous bioavailability for each study dose (10, 20 and 30 mg/d); describing dose-bioavailability relation for subcutaneous metoclopramide; comparing dose-concentration relationship of intravenous and subcutaneous metoclopramide; studying local tolerance by checking all inflammatory signs surrounding injection site; evaluating clinical efficacy by comparing between the two groups the number of vomiting episodes, use of Serotonin receptor antagonists and the nausea scores on a 11-level numerical scale.
Eighteen patients have to be analysed at least. For each patient not having completed the study, one more will be included in order to reach the eighteen necessary patients. Therefore, it is expected to include twenty-four patients. Included population characteristics will be described. A three-dimensional analysis with period, subject and dose is performed to determine metoclopramide absolute bioavailability. For secondary criteria, dose-concentration relation is analysed with a four-dimensional analysis; dose-bioavailability and dose-concentration relations are described by linear and log-linear regression. For principal purpose, only results of patients having completed the study are part of this aforementioned analyse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metoclopramide subcutaneous | Experimental | Drug: metoclopramide intravenousevery two days, first from 10 to 20 and then from 20 to 30 mg/d |
| metoclopramide intravenous | Active comparator | Drug: metoclopramide intravenousfirst from 10 to 20 and then from 20 to 30 mg/d |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| metoclopramide intravenousAlso: PrimperanAdministration route | Drug | metoclopramide intravenous, metoclopramide subcutaneous |
Primary outcome
Absolute bioavailability of SubCutaneus administration metoclopramide
Time frame: 13 days
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)
6 secondary outcomes
Absolute bioavailability of metoclopramide subcutaneously at each dose of the study (10, 20 and 30 mg / d)
Time frame: 13 days
Dose-bioavailability of metoclopramide for the SC route
Time frame: 13 days
Relations plasma concentration-dose metoclopramide subcutaneously and intravenously
Time frame: 13 days
Cutaneous inflammatory signs and subcutaneous at the puncture site
Time frame: During 13 days
Numeric scale ranging from 0 to 10 for nausea
Time frame: During 13 days
Number of vomiting in the dose level;
Time frame: During 13 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthieu FRASCA, MD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing metoclopramide intravenous in people with Nausea and Vomiting, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute bioavailability of SubCutaneus administration metoclopramide (time frame: 13 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.