UnknownPhase 2

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

United States435 participantsStarted 2020-07-01

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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, * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of Reduction in the Need for Second Endoscopy

Timeframe: 48 hours

Adverse Cardiac Side Effects related to Intervention

Timeframe: 5 days

Adverse Infectious Disease Side Effects related to Intervention

Timeframe: 30 days

Adverse Neurological Side Effects related to Intervention

Timeframe: 48 hours

Trial details

NCT IDNCT03840057

SponsorWaihong Chung

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-06

Contact for this trial

Waihong Chung, MD PhD

401-444-5280 waihong.chung@lifespan.org

View on ClinicalTrials.gov More Gastro Intestinal Bleeding trials