Gastro Intestinal BleedingPhase 2MANPURSENCT03840057

Metoclopramide, Azithromycin, or Nondrug Pretreatment for UGIB to Reduce Second Endoscopy

A Phase 2 study testing Azithromycin Injection, Metoclopramide Injectable Solution and Sodium chloride 0.9% in people with Gastro Intestinal Bleeding and Upper Gastrointestinal Bleeding, run by Waihong Chung at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Gastro Intestinal Bleeding, Upper Gastrointestinal Bleeding
What is being tested?: Azithromycin Injection, Metoclopramide Injectable Solution and Sodium chloride 0.9%
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 435 participants
Where: 1 siteUnited States
Study dates: 1 Jul 2020to Jul 2021
Phase: Phase 2
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

1. Adult patients ≥ 18 years of age at the time of presentation;
2. Admitted to Rhode Island Hospital (RIH) emergency room or inpatient services;
3. Presented with hematemesis, coffee ground emesis, or melena;
4. Upper endoscopy is planned within 24 hours of presentation or onset of bleeding.

Who cannot join

1. Known anaphylactic allergic reaction to erythromycin, azithromycin, and/or metoclopramide;
2. Concurrent use of certain medications associated with tardive dyskinesia (TD):
a. Fluphenazine,
b. Haloperidol,
c. Loxapine,
d. Paliperidone,

Show all 26Show fewer

e. Perphenazine,
f. Pimozide,
g. Risperidone,
h. Thiothixene,
i. Trifluoperazine;
3. Concurrent use of certain medications associated with torsade de pointes:
a. Amiodarone,
b. Chlorpromazine,
c. Disopyramide,
d. Dofetilide,
e. Methadone,
f. Procainamide,
g. Quinidine,
h. Sotalol;
4. Known history of TD, ventricular arrhythmias , or long QT syndrome;
5. Already received erythromycin and/or azithromycin within the past 10 days, or metoclopramide within the past 4 days for other indications;
6. Recipient of hematopoietic stem cell transplant;
7. History of Neisseria gonorrhoeae infection;
8. Pregnancy;
9. Prior gastrectomy.

Trial locations and contacts

1 site in 1 country.

Waihong Chung, MD PhD contact

401-444-5280

waihong.chung@lifespan.org

United States1 site, 1 recruiting

Rhode Island Hospital
Providence, Rhode Island, 02906
Waihong Chung, MD, PhD
Recruiting

Other trials in United States

About this study

Official title: Metoclopramide, Azithromycin, or Nondrug Pretreatment for Upper Gastrointestinal Bleeding to Reduce Second Endoscopy

Early endoscopy is an integral part of the management plan for patients presenting with clinical signs of severe or ongoing UGIB. An accurate endoscopic diagnosis and successful endoscopic hemostasis is highly dependent on adequate visualization of the entire gastric mucosa. Metoclopramide has previously been investigated as a prokinetic agent to aid gastric emptying prior to endoscopy, but its widespread adoption is limited by a lack of high quality clinical evidence as well as concerns regarding side effects. Erythromycin is currently the only prokinetic agent recommended by the American and the European guidelines for use in selected patients in order to reduce the need for second endoscopy. Its clinical application, however, is limited by risk of arrhythmia, significant drug interactions, and frequent drug shortages. Azithromycin is structurally related to erythromycin, but is devoid of most adverse side effects associated with erythromycin use. Early evidence suggests that azithromycin may be an effective alternative to erythromycin in the treatment of gastroparesis. The current study, an interventional, randomized, triple-blinded, placebo-controlled clinical trial, is primarily aimed to evaluate the effectiveness of azithromycin as a prokinetic agent in the management of UGIB. It is also aimed to further evaluate the role of metoclopramide as a prokinetic agent in this setting. Outcome measures to be collected in this study include the need for secondary endoscopy, overall mortality, transfusion requirement, length of stay, requirement for surgery, and incidence of adverse side effects. Results from this study would help identify a safe, effective, and readily available prokinetic agent to be used prior to endoscopy.

Conditions: Gastro Intestinal Bleeding, Upper Gastrointestinal Bleeding
Being tested: Azithromycin Injection, Metoclopramide Injectable Solution, Sodium chloride 0.9%
Keywords: GIB, UGIB
Medical subject headings: Gastrointestinal Hemorrhage

What participants receive

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

Azithromycin InjectionDrug
Azithromycin, a semi-synthetic macrolide antibiotic derived from erythromycin. The role of azithromycin as a prokinetic agent was first reported in a retrospective cohort study, which showed azithromycin to be equivalent to erythromycin in accelerating gastric emptying in patients with gastroparesis. The aim of this intervention arm is to evaluate the effectiveness of azithromycin as a prokinetic agent in the management of UGIB.
Metoclopramide Injectable SolutionDrug
Metoclopramide, a 5-HT4 agonist and a dopamine D2-receptor antagonist, is approved for short-term treatment of gastroparesis. The use of metoclopramide as a prokinetic agent in the setting of UGIB has been previously studied, but the number of subject involved was too low to adequately power the studies. The aim of this intervention arm is to further evaluate the effectiveness of metoclopramide as a prokinetic agent in the management of UGIB.
Sodium chloride 0.9%Drug
Normal saline is used as a placebo control.

Study groups in NCT03840057
Study group	Role	What they receive
Azithromycin	Experimental	Participants randomized to the azithromycin arm would receive 250mL of reconstituted solution containing 500mg of generic azithromycin to be administered as a slow intravenous infusion over 1 hour by the primary team 30-120 minutes prior to endoscopy. No dosage adjustment is made for those with hepatic or renal impairment. No dose adjustment is made for geriatric population. Receives: Drug: Azithromycin Injection
Metoclopramide	Experimental	Participants randomized to the metoclopramide arm would receive 2mL of solution containing 10mg of generic metoclopramide to be administered as a direct intravenous push by the primary team 5-60 minutes prior to endoscopy. No dosage adjustment is made for those with hepatic impairment. A 50% dose reduction is made for those with creatinine clearance of less than 40mL/minute. No dose adjustment is made for geriatric population. Receives: Drug: Metoclopramide Injectable Solution
Placebo	Placebo comparator	Participants randomized to the placebo arm during Part 1 (azithromycin) of the study would receive 250mL of 0.9% sodium chloride solution to be administered as a slow intravenous infusion over 1 hour by the primary team 30-120 minutes prior to endoscopy. Participants randomized to the placebo arm during Part 2 (metoclopramide) of the current study would receive 2mL of 0.9% sodium chloride solution to be administered as a direct intravenous push by the primary team 5-60 minutes prior to endoscopy. Receives: Drug: Sodium chloride 0.9%

What is being measured

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

Rate of Reduction in the Need for Second Endoscopy
The primary outcome measure of effectiveness is a reduction in the need for second endoscopy within 48 hours of the first endoscopy. This primary outcome measure is chosen because it represents the basis of current American and European guideline recommendations regarding erythromycin.
Measured: 48 hours
Adverse Cardiac Side Effects related to Intervention
The primary cardiac outcome measure is the incidence of unstable arrhythmia, occurring within 5 days of azithromycin administration, requiring cardioversion or resulting in cardiac arrest.
Measured: 5 days
Adverse Infectious Disease Side Effects related to Intervention
The primary infectious disease outcome measure is the incidence of C. difficile infection, occurring within 30 days of azithromycin administration.
Measured: 30 days
Adverse Neurological Side Effects related to Intervention
The primary neurological outcome measure is the incidence of any reversible or irreversible extrapyramidal symptom, such as acute dystonic reactions, akathisia, drug-induced Parkinsonism, and tardive dyskinesia, within 48 hours of metoclopramide administration.
Measured: 48 hours

Secondary outcomes (4)

Quality of Endoscopic Visualization
Endoscopic visibility is graded using the standard 4-point objective scoring system as described in most endoscopy literature. The corpus, fundus, and duodenal bulb are scored separately based on an independent review of the images captured by the endoscopist. If a second endoscopy is performed within 48 hours of the initial endoscopy, the presence of clinically significant lesions not identified during the first endoscopy is also measured.
Measured: 48 hours
All-Cause Mortality
All-Cause Mortality within 30 days.
Measured: 30 days.
Number of Unit of Transfusion
Number of units of packed red blood cells transfused before hemostasis has been achieved or death.
Measured: 30 days
Length of Hospital Stay
Length of hospital stay since admission for current episode of GIB.
Measured: 30 days

Timeline

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

1 Jul 2020Jul 2021

First posted15 Feb 2019
Study start1 Jul 2020
Primary completionJun 2021 (estimated)
Study completionJul 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Gastro Intestinal 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Model description: The study is comprised of two intervention arms, namely the azithromycin arm and the metoclopramide arm, as well as one placebo arm. The two interventions would be studied sequentially in order to simplify the logistical challenges of the blinding and placebo-control processes. The current study is comprised to two parts. During Part 1 of the study, participants are randomized to either azithromycin 500mg intravenous infusion or equivalent volume of 0.9% sodium chloride infusion in a 2-to-1 ratio. During Part 2 of the study, participants are randomized to either metoclopramide 10mg intravenous injection or equivalent volume of 0.9% sodium chloride injection in a 2-to-1 ratio. The 0.9% sodium chloride arm from the two parts of the study are pooled together to form the placebo arm during final analysis.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 435 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03840057
Sponsor's protocol ID: 1
Acronym: MANPURSE
Status last verified: Aug 2020
First submitted: 7 Feb 2019
Last updated: 7 Aug 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Gralnek IM, Dumonceau JM, Kuipers EJ, Lanas A, Sanders DS, Kurien M, Rotondano G, Hucl T, Dinis-Ribeiro M, Marmo R, Racz I, Arezzo A, Hoffmann RT, Lesur G, de Franchis R, Aabakken L, Veitch A, Radaelli F, Salgueiro P, Cardoso R, Maia L, Zullo A, Cipolletta L, Hassan C. Diagnosis and management of nonvariceal upper gastrointestinal hemorrhage: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2015 Oct;47(10):a1-46. doi: 10.1055/s-0034-1393172. Epub 2015 Sep 29.
PubMed 26417980
Laine L, Jensen DM. Management of patients with ulcer bleeding. Am J Gastroenterol. 2012 Mar;107(3):345-60; quiz 361. doi: 10.1038/ajg.2011.480. Epub 2012 Feb 7.
PubMed 22310222
Lee A, Kuo B. Metoclopramide in the treatment of diabetic gastroparesis. Expert Rev Endocrinol Metab. 2010;5(5):653-662. doi: 10.1586/eem.10.41.
PubMed 21278804
Larson JM, Tavakkoli A, Drane WE, Toskes PP, Moshiree B. Advantages of azithromycin over erythromycin in improving the gastric emptying half-time in adult patients with gastroparesis. J Neurogastroenterol Motil. 2010 Oct;16(4):407-13. doi: 10.5056/jnm.2010.16.4.407. Epub 2010 Oct 30.
PubMed 21103422
Moshiree B, McDonald R, Hou W, Toskes PP. Comparison of the effect of azithromycin versus erythromycin on antroduodenal pressure profiles of patients with chronic functional gastrointestinal pain and gastroparesis. Dig Dis Sci. 2010 Mar;55(3):675-83. doi: 10.1007/s10620-009-1038-3.
PubMed 19924535
Chini P, Toskes PP, Waseem S, Hou W, McDonald R, Moshiree B. Effect of azithromycin on small bowel motility in patients with gastrointestinal dysmotility. Scand J Gastroenterol. 2012 Apr;47(4):422-7. doi: 10.3109/00365521.2012.654402. Epub 2012 Feb 27.
PubMed 22364597

Want to know more?

Waihong Chung, MD PhD

401-444-5280

waihong.chung@lifespan.org

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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Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Metoclopramide, Azithromycin, or Nondrug Pretreatment for Upper Gastrointestinal Bleeding to Reduce Second Endoscopy
ClinicalTrials.gov ID: NCT03840057
Acronym / sponsor ID: MANPURSE / 1
Conditions: Gastro Intestinal Bleeding, Upper Gastrointestinal Bleeding
Keywords: GIB, UGIB
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 435 participants (estimated)
Lead sponsor: Waihong ChungUniversity, hospital or other
Study start: 1 Jul 2020 (actual)
Primary completion: Jun 2021 (estimated)
Study completion: Jul 2021 (estimated)
First posted: 15 Feb 2019 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3
Model description: The study is comprised of two intervention arms, namely the azithromycin arm and the metoclopramide arm, as well as one placebo arm. The two interventions would be studied sequentially in order to simplify the logistical challenges of the blinding and placebo-control processes. The current study is comprised to two parts. During Part 1 of the study, participants are randomized to either azithromycin 500mg intravenous infusion or equivalent volume of 0.9% sodium chloride infusion in a 2-to-1 ratio. During Part 2 of the study, participants are randomized to either metoclopramide 10mg intravenous injection or equivalent volume of 0.9% sodium chloride injection in a 2-to-1 ratio. The 0.9% sodium chloride arm from the two parts of the study are pooled together to form the placebo arm during final analysis.

Arm	Type	Receives
Azithromycin	Experimental	Drug: Azithromycin InjectionParticipants randomized to the azithromycin arm would receive 250mL of reconstituted solution containing 500mg of generic azithromycin to be administered as a slow intravenous infusion over 1 hour by the primary team 30-120 minutes prior to endoscopy. No dosage adjustment is made for those with hepatic or renal impairment. No dose adjustment is made for geriatric population.
Metoclopramide	Experimental	Drug: Metoclopramide Injectable SolutionParticipants randomized to the metoclopramide arm would receive 2mL of solution containing 10mg of generic metoclopramide to be administered as a direct intravenous push by the primary team 5-60 minutes prior to endoscopy. No dosage adjustment is made for those with hepatic impairment. A 50% dose reduction is made for those with creatinine clearance of less than 40mL/minute. No dose adjustment is made for geriatric population.
Placebo	Placebo comparator	Drug: Sodium chloride 0.9%Participants randomized to the placebo arm during Part 1 (azithromycin) of the study would receive 250mL of 0.9% sodium chloride solution to be administered as a slow intravenous infusion over 1 hour by the primary team 30-120 minutes prior to endoscopy. Participants randomized to the placebo arm during Part 2 (metoclopramide) of the current study would receive 2mL of 0.9% sodium chloride solution to be administered as a direct intravenous push by the primary team 5-60 minutes prior to endoscopy.

Who may qualify

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

Key inclusion criteria (4 listed)

1. Adult patients ≥ 18 years of age at the time of presentation;
2. Admitted to Rhode Island Hospital (RIH) emergency room or inpatient services;
3. Presented with hematemesis, coffee ground emesis, or melena;
4. Upper endoscopy is planned within 24 hours of presentation or onset of bleeding.

Key exclusion criteria (26 listed)

1. Known anaphylactic allergic reaction to erythromycin, azithromycin, and/or metoclopramide;
2. Concurrent use of certain medications associated with tardive dyskinesia (TD):
a. Fluphenazine,
b. Haloperidol,
c. Loxapine,

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
Azithromycin InjectionAzithromycin, a semi-synthetic macrolide antibiotic derived from erythromycin. The role of azithromycin as a prokinetic agent was first reported in a retrospective cohort study, which showed azithromycin to be equivalent to erythromycin in accelerating gastric emptying in patients with gastroparesis. The aim of this intervention arm is to evaluate the effectiveness of azithromycin as a prokinetic agent in the management of UGIB.	Drug	Azithromycin
Metoclopramide Injectable SolutionMetoclopramide, a 5-HT4 agonist and a dopamine D2-receptor antagonist, is approved for short-term treatment of gastroparesis. The use of metoclopramide as a prokinetic agent in the setting of UGIB has been previously studied, but the number of subject involved was too low to adequately power the studies. The aim of this intervention arm is to further evaluate the effectiveness of metoclopramide as a prokinetic agent in the management of UGIB.	Drug	Metoclopramide
Sodium chloride 0.9%Normal saline is used as a placebo control.	Drug	Placebo

Primary outcome

Rate of Reduction in the Need for Second Endoscopy
Time frame: 48 hours
The primary outcome measure of effectiveness is a reduction in the need for second endoscopy within 48 hours of the first endoscopy. This primary outcome measure is chosen because it represents the basis of current American and European guideline recommendations regarding erythromycin.
Adverse Cardiac Side Effects related to Intervention
Time frame: 5 days
The primary cardiac outcome measure is the incidence of unstable arrhythmia, occurring within 5 days of azithromycin administration, requiring cardioversion or resulting in cardiac arrest.
Adverse Infectious Disease Side Effects related to Intervention
Time frame: 30 days
The primary infectious disease outcome measure is the incidence of C. difficile infection, occurring within 30 days of azithromycin administration.
Adverse Neurological Side Effects related to Intervention
Time frame: 48 hours
The primary neurological outcome measure is the incidence of any reversible or irreversible extrapyramidal symptom, such as acute dystonic reactions, akathisia, drug-induced Parkinsonism, and tardive dyskinesia, within 48 hours of metoclopramide administration.

4 secondary outcomes

Quality of Endoscopic Visualization
Time frame: 48 hours
All-Cause Mortality
Time frame: 30 days.
Number of Unit of Transfusion
Time frame: 30 days
Length of Hospital Stay
Time frame: 30 days

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
Background: PubMed 26417980Gralnek IM, Dumonceau JM, Kuipers EJ, Lanas A, Sanders DS, Kurien M, Rotondano G, Hucl T, Dinis-Ribeiro M, Marmo R, Racz I, Arezzo A, Hoffmann RT, Lesur G, de Franchis R, Aabakken L, Veitch A, Radaelli F, Salgueiro P, Cardoso R, Maia L, Zullo A, Cipolletta L, Hassan C. Diagnosis and management of nonvariceal upper gastrointestinal hemorrhage: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2015 Oct;47(10):a1-46. doi: 10.1055/s-0034-1393172. Epub 2015 Sep 29.
Background: PubMed 22310222Laine L, Jensen DM. Management of patients with ulcer bleeding. Am J Gastroenterol. 2012 Mar;107(3):345-60; quiz 361. doi: 10.1038/ajg.2011.480. Epub 2012 Feb 7.
Background: PubMed 21278804Lee A, Kuo B. Metoclopramide in the treatment of diabetic gastroparesis. Expert Rev Endocrinol Metab. 2010;5(5):653-662. doi: 10.1586/eem.10.41.
Background: PubMed 21103422Larson JM, Tavakkoli A, Drane WE, Toskes PP, Moshiree B. Advantages of azithromycin over erythromycin in improving the gastric emptying half-time in adult patients with gastroparesis. J Neurogastroenterol Motil. 2010 Oct;16(4):407-13. doi: 10.5056/jnm.2010.16.4.407. Epub 2010 Oct 30.
Background: PubMed 19924535Moshiree B, McDonald R, Hou W, Toskes PP. Comparison of the effect of azithromycin versus erythromycin on antroduodenal pressure profiles of patients with chronic functional gastrointestinal pain and gastroparesis. Dig Dis Sci. 2010 Mar;55(3):675-83. doi: 10.1007/s10620-009-1038-3.
Background: PubMed 22364597Chini P, Toskes PP, Waseem S, Hou W, McDonald R, Moshiree B. Effect of azithromycin on small bowel motility in patients with gastrointestinal dysmotility. Scand J Gastroenterol. 2012 Apr;47(4):422-7. doi: 10.3109/00365521.2012.654402. Epub 2012 Feb 27.
Individual participant dataSharing planned: Undecided

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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.

Waihong Chung, MD PhD contact

401-444-5280

waihong.chung@lifespan.org

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

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 26 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 7 Aug 2020. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Waihong Chung, MD PhD (401-444-5280, waihong.chung@lifespan.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Reduction in the Need for Second Endoscopy (time frame: 48 hours). The study lists 4 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 NCT03840057, which also lists 6 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 7 Aug 2020.