Last updated: August 5, 2020
Sponsor: Waihong Chung
Overall Status: Active - Recruiting
Phase
2
Condition
Gastric Ulcers
Hemorrhage
Ulcers
Treatment
N/AClinical Study ID
NCT03840057
1
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Adult patients ≥ 18 years of age at the time of presentation;
- Admitted to Rhode Island Hospital (RIH) emergency room or inpatient services;
- Presented with hematemesis, coffee ground emesis, or melena;
- Upper endoscopy is planned within 24 hours of presentation or onset of bleeding.
Exclusion
Exclusion Criteria:
- Known anaphylactic allergic reaction to erythromycin, azithromycin, and/ormetoclopramide;
- 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;
- 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;
- Known history of TD, ventricular arrhythmias , or long QT syndrome;
- Already received erythromycin and/or azithromycin within the past 10 days, ormetoclopramide within the past 4 days for other indications;
- Recipient of hematopoietic stem cell transplant;
- History of Neisseria gonorrhoeae infection;
- Pregnancy;
- Prior gastrectomy.
Study Design
Total Participants: 435
Study Start date:
July 01, 2020
Estimated Completion Date:
July 31, 2021
Connect with a study center
Rhode Island Hospital
Providence, Rhode Island 02906
United StatesActive - Recruiting

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