Upper Gastrointestinal BleedingPhase 3NCT06297954
Usefulness of Metoclopramide to Improve Endoscopic Visualization in Upper Gastrointestinal Bleeding
A Phase 3 study testing Metoclopramide in people with Upper Gastrointestinal Bleeding, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
Trial summary
A prospective, randomized, double-blind study will be conducted, including all patients with upper gastrointestinal bleeding, defined as vomiting blood or black bowel movements, within 24 hours prior to admission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Gastrointestinal Bleeding
- What is being tested?
- Metoclopramide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteMexico
- Study dates
- 1 Mar 2023to 1 Jun 2024
- 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
- Hospitalized patients ≥18 years of age with variceal and non-variceal upper gastrointestinal tract bleeding (hematemesis and/or melena).
- ≤12 hours of bleeding evolution.
- Hemodynamic stability at the time of upper endoscopy.
Who cannot join
- Patients <18 years old.
- Pregnant patients.
- Metoclopramide allergy.
- Refusal to be part of the study protocol.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Universitario Dr. José Eleuterio González, UANL
Monterrey, Nuevo León, 64460
About this study
A prospective, randomized, double-blind study will be conducted, including all patients with upper gastrointestinal bleeding, defined as vomiting blood or black bowel movements, within 24 hours prior to admission. Patients will be randomized to receive intravenous metoclopramide 20 mg or placebo, a placebo is a look-alike substance that contains no active drug. Then endoscopy will be performed in the following 120 minutes, evaluating endoscopic visualization with the modified Avgerinos scale.
Read the detailed description
A prospective, longitudinal, randomized, double-blind study will be carried out in which all patients who come to the University Hospital "Dr. José Eleuterio González" with upper gastrointestinal tract bleeding, defined in our study as hematemesis or melena, including patients with this condition in the 24 hours prior to admission. Patients will be randomized to receive metoclopramide 20 mg IV or placebo, this randomization will be performed by means of a computer sequence to receive each of the treatment sequences. Subsequently, the upper endoscopy will be performed in the following 120 minutes, and the endoscopic visualization will be evaluated by the physician performing the procedure by means of the modified Avgerinos scale; which gives a score of 0-2 according to the percentage of mucosal vision; 0= <25% visible surface, 1= 25%-75% visible surface and 2= >75% visible surface, evaluating fundus, body, antrum and bulb, a score ≥ 6 will be considered a clean stomach and a score ≤ 5 will be considered full stomach. The diagnosis of origin of the upper gastrointestinal tract bleeding will be determined by the physician in charge of performing the endoscopy. All cases will be filmed and another physician will review the cases and validate the Avgerinos score, as well as the final diagnosis reported.
- Conditions
- Upper Gastrointestinal Bleeding
- Being tested
- Metoclopramide, Placebo
- Keywords
- Metoclopramide, Endoscopy, Hematemesis, Melena
- Medical subject headings
- Gastrointestinal Hemorrhage, Hematemesis, Melena
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetoclopramideDrug
Patients will receive metoclopramide 20 mg IV in a single dose prior to randomization.
PlaceboDrug
Patients will receive placebo 10 ml IV in a single dose prior to randomization.
| Study group | Role | What they receive |
|---|---|---|
| Metoclopramide | Experimental | Patients will be randomized to receive metoclopramide 20 mg IV single dose. Receives: Drug: Metoclopramide |
| Placebo | Placebo comparator | Patients will be randomized to receive placebo 10 ml IV single dose. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the usefulness of metoclopramide in improving endoscopic visualisation in patients with upper gastrointestinal bleeding.
Using modified Avgerinos scale; which gives a score of 0-2 according to the percentage of mucosal vision; 0 = <25% visible surface, 1 = 25%-75% visible surface and 2= >75% visible surface, evaluating fundus, body, antrum and bulb, a score ≥ 6 will be considered a clean stomach and a score ≤ 5 will be considered full stomach.
Measured: From admission to discharge for up to 5 days, during this time their clinical condition will be evaluated, through a general physical examination, taking vital signs and questioning them about possible side effects associated with metoclopramide
Secondary outcomes (2)
To determine whether the use of metoclopramide avoids repeating the endoscopic procedure.
The need to repeat the endoscopic procedure will be evaluated in case clinical data of new bleeding from the digestive tract, evidenced by melena or hematemesis is found.
Measured: From admission to discharge for up to 5 days, during this time it will be evaluated the need for new endoscopy in case clinical data of new bleeding from the digestive tract evidenced by melena or hematemesis.
To determine whether the use of metoclopramide shortens the length of hospital stay.
The days of hospital stay will be counted and comparing both arms.
Measured: From admission to discharge for up to 30 days, during this time their clinical condition will be evaluated, through a general physical examination, taking vital signs and questioning them about possible side effects associated with metoclopramide.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start1 Mar 2023
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Gastrointestinal BleedingStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to receive metoclopramide 20 mg IV or placebo, this randomization will be performed by means of a computer sequence to receive each of the treatment sequences. The sequence of treatment (metoclopramide) and placebo in which they will be distributed to patients will be determined using randomization software. A folio number will be assigned and depending on the sequence the treatment or placebo will be administered. Subsequently, the upper endoscopy will be performed in the following 120 minutes, and the endoscopic visualization will be evaluated by the physician performing the procedure by means of the modified Avgerinos scale
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Nuevo Leon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Luis Herrera Elizondo, Universidad Autonoma de Nuevo Leon
- Investigators
- José Luis Herrera Elizondo, Physician, Principal investigator, Hospital Universitario Dr. José Eleuterio González, UANL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297954
- Sponsor's protocol ID
- GA22-00011
- Status last verified
- Oct 2024
- First submitted
- 23 Feb 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Estes DJ, Berera S, Deshpande AR, Sussman DA. Re-Visiting Metoclopramide to Optimize Visualization with Gastrointestinal Bleeding - Mobilizing Existing Data. Clin Endosc. 2019 Sep;52(5):516-517. doi: 10.5946/ce.2019.046. Epub 2019 Jul 16. No abstract available.
PubMed 31309766
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Metoclopramide to Improve Endoscopic Visualization in Upper Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT06297954
- Acronym / sponsor ID
- GA22-00011
- Conditions
- Upper Gastrointestinal Bleeding
- Keywords
- Metoclopramide, Endoscopy, Hematemesis, Melena
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidad Autonoma de Nuevo LeonUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 7 Mar 2024 (actual)
- 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.
A prospective, randomized, double-blind study will be conducted, including all patients with upper gastrointestinal bleeding, defined as vomiting blood or black bowel movements, within 24 hours prior to admission. Patients will be randomized to receive intravenous metoclopramide 20 mg or placebo, a placebo is a look-alike substance that contains no active drug. Then endoscopy will be performed in the following 120 minutes, evaluating endoscopic visualization with the modified Avgerinos scale.
Detailed description
A prospective, longitudinal, randomized, double-blind study will be carried out in which all patients who come to the University Hospital "Dr. José Eleuterio González" with upper gastrointestinal tract bleeding, defined in our study as hematemesis or melena, including patients with this condition in the 24 hours prior to admission. Patients will be randomized to receive metoclopramide 20 mg IV or placebo, this randomization will be performed by means of a computer sequence to receive each of the treatment sequences. Subsequently, the upper endoscopy will be performed in the following 120 minutes, and the endoscopic visualization will be evaluated by the physician performing the procedure by means of the modified Avgerinos scale; which gives a score of 0-2 according to the percentage of mucosal vision; 0= <25% visible surface, 1= 25%-75% visible surface and 2= >75% visible surface, evaluating fundus, body, antrum and bulb, a score ≥ 6 will be considered a clean stomach and a score ≤ 5 will be considered full stomach. The diagnosis of origin of the upper gastrointestinal tract bleeding will be determined by the physician in charge of performing the endoscopy. All cases will be filmed and another physician will review the cases and validate the Avgerinos score, as well as the final diagnosis reported.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Patients will be randomized to receive metoclopramide 20 mg IV or placebo, this randomization will be performed by means of a computer sequence to receive each of the treatment sequences. The sequence of treatment (metoclopramide) and placebo in which they will be distributed to patients will be determined using randomization software. A folio number will be assigned and depending on the sequence the treatment or placebo will be administered. Subsequently, the upper endoscopy will be performed in the following 120 minutes, and the endoscopic visualization will be evaluated by the physician performing the procedure by means of the modified Avgerinos scale
| Arm | Type | Receives |
|---|---|---|
| Metoclopramide | Experimental | Drug: MetoclopramidePatients will be randomized to receive metoclopramide 20 mg IV single dose. |
| Placebo | Placebo comparator | Drug: PlaceboPatients will be randomized to receive placebo 10 ml IV single dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hospitalized patients ≥18 years of age with variceal and non-variceal upper gastrointestinal tract bleeding (hematemesis and/or melena).
- ≤12 hours of bleeding evolution.
- Hemodynamic stability at the time of upper endoscopy.
Key exclusion criteria (4 listed)
- Patients <18 years old.
- Pregnant patients.
- Metoclopramide allergy.
- Refusal to be part of the study protocol.
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 |
|---|---|---|
| MetoclopramidePatients will receive metoclopramide 20 mg IV in a single dose prior to randomization. | Drug | Metoclopramide |
| PlaceboPatients will receive placebo 10 ml IV in a single dose prior to randomization. | Drug | Placebo |
Primary outcome
To determine the usefulness of metoclopramide in improving endoscopic visualisation in patients with upper gastrointestinal bleeding.
Time frame: From admission to discharge for up to 5 days, during this time their clinical condition will be evaluated, through a general physical examination, taking vital signs and questioning them about possible side effects associated with metoclopramide
Using modified Avgerinos scale; which gives a score of 0-2 according to the percentage of mucosal vision; 0 = <25% visible surface, 1 = 25%-75% visible surface and 2= >75% visible surface, evaluating fundus, body, antrum and bulb, a score ≥ 6 will be considered a clean stomach and a score ≤ 5 will be considered full stomach.
2 secondary outcomes
To determine whether the use of metoclopramide avoids repeating the endoscopic procedure.
Time frame: From admission to discharge for up to 5 days, during this time it will be evaluated the need for new endoscopy in case clinical data of new bleeding from the digestive tract evidenced by melena or hematemesis.
To determine whether the use of metoclopramide shortens the length of hospital stay.
Time frame: From admission to discharge for up to 30 days, during this time their clinical condition will be evaluated, through a general physical examination, taking vital signs and questioning them about possible side effects associated with metoclopramide.
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 9 Oct 2024.
- Background: PubMed 31309766Estes DJ, Berera S, Deshpande AR, Sussman DA. Re-Visiting Metoclopramide to Optimize Visualization with Gastrointestinal Bleeding - Mobilizing Existing Data. Clin Endosc. 2019 Sep;52(5):516-517. doi: 10.5946/ce.2019.046. Epub 2019 Jul 16. No abstract available.
- Individual participant dataSharing planned: No
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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.
José Luis Herrera Elizondo, Physician principal investigator
Hospital Universitario Dr. José Eleuterio González, UANL
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 in people with Upper Gastrointestinal Bleeding, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
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 3 inclusion and 4 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 9 Oct 2024. 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 Mexico. 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. Some participants in this study may receive a placebo. 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?
To determine the usefulness of metoclopramide in improving endoscopic visualisation in patients with upper gastrointestinal bleeding. (time frame: From admission to discharge for up to 5 days, during this time their clinical condition will be evaluated, through a general physical examination, taking vital signs and questioning them about possible side effects associated with metoclopramide). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06297954, which also lists 1 linked publication.
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 9 Oct 2024.