Upper GI BleedingPhase 4NCT05746377
Metoclopramide in Upper Gastrointestinal Bleed
A Phase 4 study testing Metoclopramide 10mg and Saline in people with Upper GI Bleeding and Bleeds Gastric, run by Mercy Health System at 1 site in United States.
Trial summary
The goal of this clinical trial is to test if metoclopramide can improve effectiveness of endoscopic intervention in upper gastrointestinal (GI) bleeds. The main questions the investigators hope to answer is Does metoclopramide lessen the need for repeat endoscopy, interventional radiology intervention or surgery in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Upper GI Bleeding, Bleeds Gastric, Bleed Ulcer
- What is being tested?
- Metoclopramide 10mg and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2023to Jun 2024
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 and above
- Admitted to ER or inpatient services at Javon Bea Hospital MercyHealth Riverside
- Present with upper GI bleeding defined as fresh and bright red hematemesis, coffee-ground hematemesis or melena
- Plan to undergo EGD within 24 hours since admission or since first symptoms
- Calculated Glasgow-Blatchford score ≥ 2
Who cannot join
- Failure to obtain informed consent
- Known allergy to metoclopramide
- Concurrent use of medications known to cause tardive dyskinesia (TD)/extrapyramidal symptoms/neuroleptic malignant syndrome
- History of TD or dystonic reaction to metoclopramide
- Pheochromocytoma, catecholamine-releasing paragangliomas
- Parkinson's Disease
Show all 9Show fewer
- Epilepsy
- Pregnancy or lactation
- Previous gastrectomy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Javon Bea Hospital-Riverside - MercyHealth
Rockford, Illinois, 61114
Altaf Dawood, 815-971-7000
About this study
Official title: Premedication With Metoclopramide in Upper Gastrointestinal Bleeds a Prospective Double Blinded Single Center Randomized Control Trial in a Small Community Hospital
The goal of this clinical trial is to test if metoclopramide can improve effectiveness of endoscopic intervention in upper gastrointestinal (GI) bleeds. The main questions the investigators hope to answer is
Does metoclopramide lessen the need for repeat endoscopy, interventional radiology intervention or surgery in cases of upper GI bleed?
Does metoclopramide improve visibility of the GI walls in cases of upper GI bleed?
Read the detailed description
The purpose of the study is to see if giving metoclopramide prior to an endoscopy in cases of upper GI bleed can decrease the need for repeat endoscopy due to poor visibility. Metoclopramide stimulates stomach and intestine activity. It is used to treat nausea, vomiting and slow gut movement. The investigators are testing if metoclopramide's effect on stimulating stomach activity can lead to more effective emptying of blood from the stomach and upper intestines in upper GI bleeding so physicians conducting endoscopies can easily see the stomach and intestinal wall and treat the source of bleeding.
- Being tested
- Metoclopramide 10mg, Saline
- Keywords
- metoclopramide, prokinetic, Upper endoscopy, EGD, endoscopic gastroduodenoscopy, esophagogastroduodenoscopy
- Medical subject headings
- Gastrointestinal Hemorrhage, Hemorrhage, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metoclopramide 10mgDrug
Also called Reglan
IV Metoclopramide
SalineDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Metoclopramide | Experimental | Given 10 mg Metoclopramide prior to Endoscopy Receives: Drug: Metoclopramide 10mg |
| Placebo | Placebo comparator | Given saline flush prior to Endoscopy Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for repeat endoscopy, Interventional Radiology Intervention or Surgery due to poor visibility
Will collect if repeat procedure occurred due to poor visibility (True/False)
Measured: During Current Hospitalization (up to day 14)
Toronto Upper Gastroenterology Cleaning Score (TUGS)
Standardized 0-12 point scale for describing upper gastrointestinal tract visibility, 0 indicating poor visibility, and 12 indicating excellent visibility
Measured: During Endoscopy Procedure
Secondary outcomes (6)
Length of Hospital stay (days)
Time in days between admission and discharge
Measured: During Current Hospitalization (up to day 14)
Types of Adverse Neurological Side effects
Dystonia, Akathisia, Parkinsonism, Tardive Dyskinesia, Other
Measured: 3 month f/u
Glasgow-Blatchford Bleeding Score
Score from 0-29 estimating risk of gastrointestinal bleed and need for inpatient admission, 0 indicating low risk, 29 indicating high risk of mortality
Measured: within 3 hours after admission
Endoscopy Findings
Findings of endoscopy
Measured: During Endoscopy Procedure
Endoscopy Start and End Times
Start and stop times of endoscopies
Measured: During Endoscopy Procedure
Number of Blood Units Transfused in 24 hours
measure in units of blood transfused
Measured: within 24 hours after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start20 May 2023
- Primary completionFeb 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Upper GI 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mercy Health System
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Mudassar Sandozi, Mercy Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746377
- Sponsor's protocol ID
- #323
- Status last verified
- Jul 2023
- First submitted
- 8 Feb 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barkun AN, Bardou M, Martel M, Gralnek IM, Sung JJ. Prokinetics in acute upper GI bleeding: a meta-analysis. Gastrointest Endosc. 2010 Dec;72(6):1138-45. doi: 10.1016/j.gie.2010.08.011.
PubMed 20970794Khan R, Gimpaya N, Vargas JI, Ramkissoon A, Seleq S, Gholami R, Akhtar HJ, Bansal R, Scaffidi MA, Amin S, Bollipo S, Kral J, Lui R, Pawlak KM, Sandhu DS, Bilal M, de-Madaria E, Siau K, Charabaty A, Hashim A, Sanchez-Luna SA, Teshima CW, May GR, Mosko JD, Walsh CM, Grover SC. The Toronto Upper Gastrointestinal Cleaning Score: a prospective validation study. Endoscopy. 2023 Feb;55(2):121-128. doi: 10.1055/a-1865-4180. Epub 2022 May 31.
PubMed 35642290Daram SR, Garretson R. Erythromycin is preferable to metoclopramide as a prokinetic in acute upper GI bleeding. Gastrointest Endosc. 2011 Jul;74(1):234; author reply 234-5. doi: 10.1016/j.gie.2011.01.059. No abstract available.
PubMed 21704823Laine L, Barkun AN, Saltzman JR, Martel M, Leontiadis GI. ACG Clinical Guideline: Upper Gastrointestinal and Ulcer Bleeding. Am J Gastroenterol. 2021 May 1;116(5):899-917. doi: 10.14309/ajg.0000000000001245.
PubMed 33929377Metoclopramide for Acute Upper GI Bleeding - Tabular View - ClinicalTrials.Gov. https://clinicaltrials.gov/ct2/show/record/NCT04771481. Accessed 7 Feb. 2023.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premedication With Metoclopramide in Upper Gastrointestinal Bleeds a Prospective Double Blinded Single Center Randomized Control Trial in a Small Community Hospital
- ClinicalTrials.gov ID
- NCT05746377
- Acronym / sponsor ID
- #323
- Keywords
- metoclopramide, prokinetic, Upper endoscopy, EGD, endoscopic gastroduodenoscopy, esophagogastroduodenoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mercy Health SystemResearch network
- Study start
- 20 May 2023 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 27 Feb 2023 (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.
The goal of this clinical trial is to test if metoclopramide can improve effectiveness of endoscopic intervention in upper gastrointestinal (GI) bleeds. The main questions the investigators hope to answer is
Does metoclopramide lessen the need for repeat endoscopy, interventional radiology intervention or surgery in cases of upper GI bleed?
Does metoclopramide improve visibility of the GI walls in cases of upper GI bleed?
Detailed description
The purpose of the study is to see if giving metoclopramide prior to an endoscopy in cases of upper GI bleed can decrease the need for repeat endoscopy due to poor visibility. Metoclopramide stimulates stomach and intestine activity. It is used to treat nausea, vomiting and slow gut movement. The investigators are testing if metoclopramide's effect on stimulating stomach activity can lead to more effective emptying of blood from the stomach and upper intestines in upper GI bleeding so physicians conducting endoscopies can easily see the stomach and intestinal wall and treat the source of bleeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metoclopramide | Experimental | Drug: Metoclopramide 10mgGiven 10 mg Metoclopramide prior to Endoscopy |
| Placebo | Placebo comparator | Drug: SalineGiven saline flush prior to Endoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 and above
- Admitted to ER or inpatient services at Javon Bea Hospital MercyHealth Riverside
- Present with upper GI bleeding defined as fresh and bright red hematemesis, coffee-ground hematemesis or melena
- Plan to undergo EGD within 24 hours since admission or since first symptoms
- Calculated Glasgow-Blatchford score ≥ 2
Key exclusion criteria (9 listed)
- Failure to obtain informed consent
- Known allergy to metoclopramide
- Concurrent use of medications known to cause tardive dyskinesia (TD)/extrapyramidal symptoms/neuroleptic malignant syndrome
- History of TD or dystonic reaction to metoclopramide
- Pheochromocytoma, catecholamine-releasing paragangliomas
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 10mgAlso: ReglanIV Metoclopramide | Drug | Metoclopramide |
| SalinePlacebo | Drug | Placebo |
Primary outcome
Need for repeat endoscopy, Interventional Radiology Intervention or Surgery due to poor visibility
Time frame: During Current Hospitalization (up to day 14)
Will collect if repeat procedure occurred due to poor visibility (True/False)
Toronto Upper Gastroenterology Cleaning Score (TUGS)
Time frame: During Endoscopy Procedure
Standardized 0-12 point scale for describing upper gastrointestinal tract visibility, 0 indicating poor visibility, and 12 indicating excellent visibility
6 secondary outcomes
Length of Hospital stay (days)
Time frame: During Current Hospitalization (up to day 14)
Types of Adverse Neurological Side effects
Time frame: 3 month f/u
Glasgow-Blatchford Bleeding Score
Time frame: within 3 hours after admission
Endoscopy Findings
Time frame: During Endoscopy Procedure
Endoscopy Start and End Times
Time frame: During Endoscopy Procedure
Number of Blood Units Transfused in 24 hours
Time frame: within 24 hours after admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Background: PubMed 20970794Barkun AN, Bardou M, Martel M, Gralnek IM, Sung JJ. Prokinetics in acute upper GI bleeding: a meta-analysis. Gastrointest Endosc. 2010 Dec;72(6):1138-45. doi: 10.1016/j.gie.2010.08.011.
- Background: PubMed 35642290Khan R, Gimpaya N, Vargas JI, Ramkissoon A, Seleq S, Gholami R, Akhtar HJ, Bansal R, Scaffidi MA, Amin S, Bollipo S, Kral J, Lui R, Pawlak KM, Sandhu DS, Bilal M, de-Madaria E, Siau K, Charabaty A, Hashim A, Sanchez-Luna SA, Teshima CW, May GR, Mosko JD, Walsh CM, Grover SC. The Toronto Upper Gastrointestinal Cleaning Score: a prospective validation study. Endoscopy. 2023 Feb;55(2):121-128. doi: 10.1055/a-1865-4180. Epub 2022 May 31.
- Background: PubMed 21704823Daram SR, Garretson R. Erythromycin is preferable to metoclopramide as a prokinetic in acute upper GI bleeding. Gastrointest Endosc. 2011 Jul;74(1):234; author reply 234-5. doi: 10.1016/j.gie.2011.01.059. No abstract available.
- Background: PubMed 33929377Laine L, Barkun AN, Saltzman JR, Martel M, Leontiadis GI. ACG Clinical Guideline: Upper Gastrointestinal and Ulcer Bleeding. Am J Gastroenterol. 2021 May 1;116(5):899-917. doi: 10.14309/ajg.0000000000001245.
- BackgroundMetoclopramide for Acute Upper GI Bleeding - Tabular View - ClinicalTrials.Gov. https://clinicaltrials.gov/ct2/show/record/NCT04771481. Accessed 7 Feb. 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metoclopramide 10mg and Saline in people with Upper GI Bleeding and Bleeds Gastric, run by Mercy Health System at 1 site in United States.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 11 Jul 2023. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mudassar K Sandozi, DO ((815) 971-2544, msandozi@mhemail.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for repeat endoscopy, Interventional Radiology Intervention or Surgery due to poor visibility (time frame: During Current Hospitalization (up to day 14)). The study lists 2 primary outcomes in all. 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 NCT05746377, which also lists 5 linked publications.
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 11 Jul 2023.