Upper Gastrointestinal BleedingNCT02017379

Randomized Control Trial Comparing Prokinetics and Their Influence on Endoscopy Outcomes for Upper GI Bleed.

A study testing Erythromycin and Metoclopromide in people with Upper Gastrointestinal Bleeding, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is a study comparing the effect of erythromycin or metoclopramide, 2 prokinetic drugs (Drugs which are known to speed up the emptying of the stomach or in other words to move the blood out of the stomach faster) given before endoscopy to patients with upper Gastrointestinal bleeding compared to patients who will… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Upper Gastrointestinal Bleeding
What is being tested?: Erythromycin and Metoclopromide
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 1 siteUnited States
Study dates: Jun 2014to Sep 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult patients (18-80)
who are admitted to the ICU for hematemesis, or coffee ground emesis

Who cannot join

Patients younger than 18 yrs old or older than 80 yrs
Patients who refuse to consent to be in our study
Pregnant patients
Prior use of prokinetics in the last 48 hours
History of cardiac arrhythmia
Allergy to erythromycin or metoclopromide
Patients with QT prolongation (query 7)
-

Trial locations and contacts

1 site in 1 country.

United States1 site

Texas Tech University Health Science Center
El Paso, Texas, 79905

Other trials in United States

About this study

Read the detailed description

To compare the efficacy of pre-endoscopic interventions namely erythromycin, metoclopromide vs control in improving the outcomes of endoscopy in ICU patients admitted upper GI bleeding.

Specific aims:

Wither erythromycin, metoclopromide vs control can enable visualization of the entire gastric mucosa .
Wither erythromycin, metoclopromide vs control can improve the quality of stomach and duodenum visualization: using the scoring system by Fossard et al

Conditions: Upper Gastrointestinal Bleeding
Being tested: Erythromycin, Metoclopromide
Keywords: upper gastrointestinal bleeding, melena, hematemesis
Medical subject headings: Gastrointestinal Hemorrhage, Melena, Hematemesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ErythromycinDrug
Also called Erythrocin, E-Mycin, Ery-Tab, Ilosone
MetoclopromideDrug
Also called Reglan, Maxolon, Metozolv ODT

Study groups in NCT02017379
Study group	Role	What they receive
Erythromycin	Experimental	Intravenous erythromycin infusion (dose: 250 mg) 30 min-60 min before procedure Receives: Drug: Erythromycin
Metoclopromide	Experimental	Intravenous metoclopromide infusion (dose: 10 mg) 30-60 minutes prior to endoscopy Receives: Drug: Metoclopromide
Control	No intervention	no medications will be given prior to endoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

Erythromycin, Metoclopromide vs Control Enabling Visualization of the Entire Gastric Mucosa .
Whether erythromycin, metoclopramide versus control can enable visualization of the entire gastric mucosa .
Measured: 45 minutes
Erythromycin, Metoclopromide vs Control Improving the Quality of Stomach and Duodenum Visualization
Whether erythromycin, metoclopramide vs control can improve the quality of stomach and duodenum visualization: using the scoring system by Fossard et al
Measured: 45 minutes

Secondary outcomes (4)

Source of Bleeding
Ability to identify the source of bleeding
Measured: 45 minutes
Second-look Endoscopy
Need for second-look endoscopy
Measured: 48 hours
Blood Units Transfused
Mean number of blood units transfused
Measured: 48 hours
Mortality
All cause mortality
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014Sep 2014

First posted20 Dec 2013 (estimated)
Study startJun 2014
Primary completionSep 2014
Study completionSep 2014

Why it stopped: Could not recruit any subjects

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02017379
Sponsor's protocol ID: E13018
Status last verified: Feb 2021
First submitted: 16 Dec 2013
Last updated: 4 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Zastaprazan for the prEvention of Upper GI Bleeding in Ischemic Stroke
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All Upper Gastrointestinal Bleeding trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Control Trial Comparing Prokinetics and Their Influence on Endoscopy Outcomes for Upper GI Bleed.
ClinicalTrials.gov ID: NCT02017379
Acronym / sponsor ID: E13018
Conditions: Upper Gastrointestinal Bleeding
Keywords: upper gastrointestinal bleeding, melena, hematemesis
Study type: Interventional
Recruitment status: TerminatedReason stopped: Could not recruit any subjects
Enrolment: 4 participants (actual)
Lead sponsor: Texas Tech University Health Sciences Center, El PasoUniversity, hospital or other
Study start: Jun 2014
Primary completion: Sep 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 20 Dec 2013 (estimated)
Results: Posted 4 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

To compare the efficacy of pre-endoscopic interventions namely erythromycin, metoclopromide vs control in improving the outcomes of endoscopy in ICU patients admitted upper GI bleeding.

Specific aims:

Wither erythromycin, metoclopromide vs control can enable visualization of the entire gastric mucosa .
Wither erythromycin, metoclopromide vs control can improve the quality of stomach and duodenum visualization: using the scoring system by Fossard et al

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Erythromycin	Experimental	Drug: ErythromycinIntravenous erythromycin infusion (dose: 250 mg) 30 min-60 min before procedure
Metoclopromide	Experimental	Drug: MetoclopromideIntravenous metoclopromide infusion (dose: 10 mg) 30-60 minutes prior to endoscopy
Control	No intervention	–no medications will be given prior to endoscopy

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Adult patients (18-80)
who are admitted to the ICU for hematemesis, or coffee ground emesis

Key exclusion criteria (8 listed)

Patients younger than 18 yrs old or older than 80 yrs
Patients who refuse to consent to be in our study
Pregnant patients
Prior use of prokinetics in the last 48 hours
History of cardiac arrhythmia

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
ErythromycinAlso: Erythrocin, E-Mycin, Ery-Tab, Ilosone	Drug	Erythromycin
MetoclopromideAlso: Reglan, Maxolon, Metozolv ODT	Drug	Metoclopromide

Primary outcome

Erythromycin, Metoclopromide vs Control Enabling Visualization of the Entire Gastric Mucosa .
Time frame: 45 minutes
Whether erythromycin, metoclopramide versus control can enable visualization of the entire gastric mucosa .
Erythromycin, Metoclopromide vs Control Improving the Quality of Stomach and Duodenum Visualization
Time frame: 45 minutes
Whether erythromycin, metoclopramide vs control can improve the quality of stomach and duodenum visualization: using the scoring system by Fossard et al

4 secondary outcomes

Source of Bleeding
Time frame: 45 minutes
Second-look Endoscopy
Time frame: 48 hours
Blood Units Transfused
Time frame: 48 hours
Mortality
Time frame: 30 days

Results and safety

Results posted to the registry on 4 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Erythromycin	0	0
Metoclopromide	0	0
Control	0	0

Primary outcome: Erythromycin, Metoclopromide vs Control Enabling Visualization of the Entire Gastric Mucosa .

Time frame: 45 minutes

Population analysed: The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.

Primary outcome: Erythromycin, Metoclopromide vs Control Improving the Quality of Stomach and Duodenum Visualization

Time frame: 45 minutes

Population analysed: The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Erythromycin	0 of 0	0 of 0
Metoclopromide	0 of 0	0 of 0
Control	0 of 0	0 of 0

Limitations and caveats (from the sponsor): The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Upper Gastrointestinal Bleeding

Recruiting
OTSC vs. Angiographic Embolization in Patients With Refractory Non-variceal Upper Gastrointestinal Bleeding
Upper Gastrointestinal Bleeding
Recruiting
Fexuprazan for Prevention of Upper Gastrointestinal Bleeding in High Bleeding Risk Patients Receiving Dual Antiplatelet Therapy
Acute Coronary Syndromes (ACS), Coronary Artery Disease (CAD)
Not yet recruitingPhase 3
Zastaprazan for the prEvention of Upper GI Bleeding in Ischemic Stroke
Ischemic Stroke, Transient Ischemic Attack
Recruiting
Detection of Blood in the GI Lumen With HemoPill Acute
Upper GI Bleeding
Active, not recruitingObservational study
Impact of Diagnostic and Therapeutic Upper and Lower Gastrointestinal Endoscopic Management on Critically Ill Patients in Fayoum University Hospitals
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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.

Mohamed O Othman, MD principal investigator

Texas Tech University Health Sciences Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Erythromycin and Metoclopromide in people with Upper Gastrointestinal Bleeding, run by Texas Tech University Health Sciences Center, El Paso 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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 4 Mar 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Erythromycin, Metoclopromide vs Control Enabling Visualization of the Entire Gastric Mucosa . (time frame: 45 minutes). 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 NCT02017379.

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 4 Mar 2021.