Upper GI BleedingPhase 4NCT06167837
Metoclopramide for Gastric Visualization in Active Upper GI Bleeding
A Phase 4 study testing Metoclopramide Sulfone and Normal Saline 10 mL Injection in people with Upper GI Bleeding, run by King Chulalongkorn Memorial Hospital at 2 sites in Thailand.
Trial summary
This study aim to evaluate the efficacy of metoclopramide for gastric visualization in patients with active UGIB. This is a double-blinded, multicenter RCT. Patients with 'active' UGIB (hematemesis or presence of fresh blood in the nasogastric tube) were enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper GI Bleeding
- What is being tested?
- Metoclopramide Sulfone and Normal Saline 10 mL Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 2 sitesThailand
- Study dates
- 1 Oct 2023to 30 Jun 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients (aged ≥ 18years)
- Active UGIB who arrived at emergency room (ER) and had a schedule for EGD within 12 hours after onset of bleeding ; Active UGIB was defined as having hematemesis or fresh blood by diagnostic gastric lavage at the ER.
Who cannot join
- known allergy to metoclopramide
- prior gastric or duodenal surgery
- known case of esophageal, gastric or duodenal cancer;
- advanced HIV infection (defined as WHO criteria13-15: CD4 <200 cell/mm3 or WHO clinical stage 3 or 4)
- pregnancy
- gastric lavage was performed with solution > 50 ml.
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites, 2 recruiting
- Recruiting
King Chulalongkorn memorial hospital
Bangkok, 10330
Thanrada Vimonsuntirungsri, MD, +66853356240, aa_choc@docchula.com
- Not yet recruiting
King Chulalongkorn Memorial hospital
Bangkok, 10330
Thanrada Vimonsuntirungsri, 66853356240, aa_choc@docchula.com
Thanrada Vimonsuntirungsri, MD
About this study
Official title: Efficacy of Metoclopramide for Gastric Visualization by Endoscopy in Patients With Active Upper Gastrointestinal Bleeding: Multicenter, Double-blind Randomized Controlled Trial
This study aim to evaluate the efficacy of metoclopramide for gastric visualization in patients with active UGIB. This is a double-blinded, multicenter RCT. Patients with 'active' UGIB (hematemesis or presence of fresh blood in the nasogastric tube) were enrolled. The eligible patients were randomly assigned in a concealed 1:1 allocation to received either intravenous metoclopramide or placebo before endoscopy. The primary outcome was 'adequate visualization' by objective endoscopic visualized scores(EVS). Secondary outcomes included mean difference in total EVS and EVS at each location , duration of EGD, immediate hemostasis, need for a second look EGD, units of blood transfusion, length of hospital stay and 30-day rebleeding rate.
Read the detailed description
- This is double-blinded, multicenter RCT including six hospitals in Thailand.
- The participated endoscopists had work experience for endoscopy more than three years.
- All endoscopists at six participating sites attended the pre-study meeting for standardization of the protocol and scoring system.
- The primary outcome was 'adequate visualization' by objective endoscopic visualized scores(EVS). ; To assess overall endoscopic visualization, we estimated the coverage of a blood clot on mucosa in four locations including 1) gastric fundus, 2) corpus, 3) antrum and 4) duodenal bulb, according to the reference endoscopic views in protocal.
- All photos, including the reference endoscopic views, were taken and internally validated by another endoscopist who was blinded to the randomization allocation.
- This study includes pre-specified subgroup analysis by location of bleeding including gastric subgroup analysis.
- Conditions
- Upper GI Bleeding
- Being tested
- Metoclopramide Sulfone, Normal Saline 10 mL Injection
- Keywords
- active upper GI bleeding, EGD, Gastric visualization, Metoclopramide
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metoclopramide SulfoneDrug
Metoclopramide 10mg+NSS 10 ml IV 30-60 minutes before EGD
Normal Saline 10 mL InjectionDrug
Normal saline 10 ml IV 30-60 minutes before EGD
| Study group | Role | What they receive |
|---|---|---|
| Metoclopramide group | Experimental | Metoclopramide 10 mg +NSS 10ml IV 30-60 min before EGD Receives: Drug: Metoclopramide Sulfone |
| Placebo group | Placebo comparator | NSS 10 ml IV 30-60 min before EGD Receives: Drug: Normal Saline 10 mL Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with 'adequate visualization'
'adequate visualization' is determined by objective scoring method (endoscopic visualized scores (EVS) to estimate the coverage of a blood clot on mucosa in four locations including 1) gastric fundus, 2) corpus, 3) antrum and 4) duodenal bulb; At each location was assessed and scored between 0 and 2: 0, blood clot cover more than 75% of the surface ; 1, 25-75% blood clot coverage ; 2, blood clot coverage less than 25%. ; score >=6 considered as adequate visualization
Measured: Through study completion, estimate 2 years
Secondary outcomes (7)
The mean difference in EVS
total of four locations and at each location including fundus, corpus, antrum and duodenal bulb
Measured: Through study completion, estimate 2 years
Duration of esophagogastroduodenoscopy
Measured: 10minutes to 2 hours
Immediate hemostasis
Rate of succession of hemostasis (bleeding stop) at first EGD
Measured: Through study completion, estimate 2 years
The need for a second look EGD within 72 hours after initial endoscopy
Rate of need for a second look EGD within 72 hours after initial endoscopy The 72-hour recurrent GI bleeding was documented and re-EGD was performed to confirm rebleeding if the following conditions were met: I) hematemesis or bloody nasogastric tube (NG) > 6 hours after endoscopy; II) melena after normalization of stool color; III) hematochezia after normalization of stool color or melena; IV) development of tachycardia (HR ≥ 110 bpm) or hypotension(SBP ≤ 90 mmHg) after ≥ 1 hour of vital sign stability without other cause; V) hemoglobin drop of ≥ 2 g/dL after two consecutive stable hemoglobin values ( < 0.5 g/dL decrease) ≥ 3 hours apart; VI) tachycardia or hypotension that does not resolve within 8 hours after index endoscopy despite appropriate resuscitation (in the absence of an alternative explanation), associated with persistent melena or hematochezia or; VII) persistently dropping hemoglobin of > 3 g/dL in 24 hours associated with persistent melena or hematochezia.
Measured: Up to 72 hours
Number of unit of red blood cell transfusion during first 24 hours
Number of of unit of red blood cell transfusions during first 24 hours
Measured: Up to 24 hours
Length of hospital stays
Length of hospital stays of participants
Measured: 1day - 30days
30-day rebleeding rate
rate of 30-day rebleeding of upper GI tract
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start1 Oct 2023
- Primary completion1 May 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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, Investigator
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Chulalongkorn Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rapat Pittayanon, King Chulalongkorn Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167837
- Sponsor's protocol ID
- Metoclopramide.UGIB
- Status last verified
- Dec 2023
- First submitted
- 30 Sep 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Metoclopramide for Gastric Visualization by Endoscopy in Patients With Active Upper Gastrointestinal Bleeding: Multicenter, Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06167837
- Acronym / sponsor ID
- Metoclopramide.UGIB
- Conditions
- Upper GI Bleeding
- Keywords
- active upper GI bleeding, EGD, Gastric visualization, Metoclopramide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- King Chulalongkorn Memorial HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 13 Dec 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.
This study aim to evaluate the efficacy of metoclopramide for gastric visualization in patients with active UGIB. This is a double-blinded, multicenter RCT. Patients with 'active' UGIB (hematemesis or presence of fresh blood in the nasogastric tube) were enrolled. The eligible patients were randomly assigned in a concealed 1:1 allocation to received either intravenous metoclopramide or placebo before endoscopy. The primary outcome was 'adequate visualization' by objective endoscopic visualized scores(EVS). Secondary outcomes included mean difference in total EVS and EVS at each location , duration of EGD, immediate hemostasis, need for a second look EGD, units of blood transfusion, length of hospital stay and 30-day rebleeding rate.
Detailed description
- This is double-blinded, multicenter RCT including six hospitals in Thailand.
- The participated endoscopists had work experience for endoscopy more than three years.
- All endoscopists at six participating sites attended the pre-study meeting for standardization of the protocol and scoring system.
- The primary outcome was 'adequate visualization' by objective endoscopic visualized scores(EVS). ; To assess overall endoscopic visualization, we estimated the coverage of a blood clot on mucosa in four locations including 1) gastric fundus, 2) corpus, 3) antrum and 4) duodenal bulb, according to the reference endoscopic views in protocal.
- All photos, including the reference endoscopic views, were taken and internally validated by another endoscopist who was blinded to the randomization allocation.
- This study includes pre-specified subgroup analysis by location of bleeding including gastric subgroup analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metoclopramide group | Experimental | Drug: Metoclopramide SulfoneMetoclopramide 10 mg +NSS 10ml IV 30-60 min before EGD |
| Placebo group | Placebo comparator | Drug: Normal Saline 10 mL InjectionNSS 10 ml IV 30-60 min before EGD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All adult patients (aged ≥ 18years)
- Active UGIB who arrived at emergency room (ER) and had a schedule for EGD within 12 hours after onset of bleeding ; Active UGIB was defined as having hematemesis or fresh blood by diagnostic gastric lavage at the ER.
Key exclusion criteria (6 listed)
- known allergy to metoclopramide
- prior gastric or duodenal surgery
- known case of esophageal, gastric or duodenal cancer;
- advanced HIV infection (defined as WHO criteria13-15: CD4 <200 cell/mm3 or WHO clinical stage 3 or 4)
- pregnancy
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 SulfoneMetoclopramide 10mg+NSS 10 ml IV 30-60 minutes before EGD | Drug | Metoclopramide group |
| Normal Saline 10 mL InjectionNormal saline 10 ml IV 30-60 minutes before EGD | Drug | Placebo group |
Primary outcome
Percentage of patients with 'adequate visualization'
Time frame: Through study completion, estimate 2 years
'adequate visualization' is determined by objective scoring method (endoscopic visualized scores (EVS) to estimate the coverage of a blood clot on mucosa in four locations including 1) gastric fundus, 2) corpus, 3) antrum and 4) duodenal bulb; At each location was assessed and scored between 0 and 2: 0, blood clot cover more than 75% of the surface ; 1, 25-75% blood clot coverage ; 2, blood clot coverage less than 25%. ; score >=6 considered as adequate visualization
7 secondary outcomes
The mean difference in EVS
Time frame: Through study completion, estimate 2 years
Duration of esophagogastroduodenoscopy
Time frame: 10minutes to 2 hours
Immediate hemostasis
Time frame: Through study completion, estimate 2 years
The need for a second look EGD within 72 hours after initial endoscopy
Time frame: Up to 72 hours
Number of unit of red blood cell transfusion during first 24 hours
Time frame: Up to 24 hours
Length of hospital stays
Time frame: 1day - 30days
30-day rebleeding rate
Time frame: Up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 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.
2 sites 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 Sulfone and Normal Saline 10 mL Injection in people with Upper GI Bleeding, run by King Chulalongkorn Memorial Hospital at 2 sites in Thailand.
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 2 inclusion and 6 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 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. 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 Thanrada Vimonsuntirungsri, MD (+66853356240, aa_choc@docchula.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with 'adequate visualization' (time frame: Through study completion, estimate 2 years). 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 13 Dec 2023.