<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03840057</url>
  </required_header>
  <id_info>
    <org_study_id>1</org_study_id>
    <nct_id>NCT03840057</nct_id>
  </id_info>
  <brief_title>Metoclopramide, Azithromycin, or Nondrug Pretreatment for UGIB to Reduce Second Endoscopy</brief_title>
  <acronym>MANPURSE</acronym>
  <official_title>Metoclopramide, Azithromycin, or Nondrug Pretreatment for Upper Gastrointestinal Bleeding to Reduce Second Endoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Waihong Chung</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lifespan</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Early endoscopy is an integral part of the management plan for patients presenting with&#xD;
      clinical signs of severe or ongoing UGIB. An accurate endoscopic diagnosis and successful&#xD;
      endoscopic hemostasis is highly dependent on adequate visualization of the entire gastric&#xD;
      mucosa. Metoclopramide has previously been investigated as a prokinetic agent to aid gastric&#xD;
      emptying prior to endoscopy, but its widespread adoption is limited by a lack of high quality&#xD;
      clinical evidence as well as concerns regarding side effects. Erythromycin is currently the&#xD;
      only prokinetic agent recommended by the American and the European guidelines for use in&#xD;
      selected patients in order to reduce the need for second endoscopy. Its clinical application,&#xD;
      however, is limited by risk of arrhythmia, significant drug interactions, and frequent drug&#xD;
      shortages. Azithromycin is structurally related to erythromycin, but is devoid of most&#xD;
      adverse side effects associated with erythromycin use. Early evidence suggests that&#xD;
      azithromycin may be an effective alternative to erythromycin in the treatment of&#xD;
      gastroparesis. The current study, an interventional, randomized, triple-blinded,&#xD;
      placebo-controlled clinical trial, is primarily aimed to evaluate the effectiveness of&#xD;
      azithromycin as a prokinetic agent in the management of UGIB. It is also aimed to further&#xD;
      evaluate the role of metoclopramide as a prokinetic agent in this setting. Outcome measures&#xD;
      to be collected in this study include the need for secondary endoscopy, overall mortality,&#xD;
      transfusion requirement, length of stay, requirement for surgery, and incidence of adverse&#xD;
      side effects. Results from this study would help identify a safe, effective, and readily&#xD;
      available prokinetic agent to be used prior to endoscopy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">July 2021</completion_date>
  <primary_completion_date type="Anticipated">June 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_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.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Initial management of UGIB would be performed by the primary team without interference from the investigator. If a gastroenterology consult were placed by the primary team, the endoscopist on-call would evaluate the patient per routine care. If an early endoscopy is deemed appropriate and necessary based on the patient's clinical status, the participant is registered to a central electronic database, which would assign participants to the intervention arm or the placebo arm using a permuted block randomization process. The appropriate medication or placebo is prepared and distributed by the central inpatient pharmacy. The investigator, the endoscopist, the study participant, and the primary team are all blinded to the assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of Reduction in the Need for Second Endoscopy</measure>
    <time_frame>48 hours</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse Cardiac Side Effects related to Intervention</measure>
    <time_frame>5 days</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse Infectious Disease Side Effects related to Intervention</measure>
    <time_frame>30 days</time_frame>
    <description>The primary infectious disease outcome measure is the incidence of C. difficile infection, occurring within 30 days of azithromycin administration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse Neurological Side Effects related to Intervention</measure>
    <time_frame>48 hours</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Endoscopic Visualization</measure>
    <time_frame>48 hours</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-Cause Mortality</measure>
    <time_frame>30 days.</time_frame>
    <description>All-Cause Mortality within 30 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Unit of Transfusion</measure>
    <time_frame>30 days</time_frame>
    <description>Number of units of packed red blood cells transfused before hemostasis has been achieved or death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Hospital Stay</measure>
    <time_frame>30 days</time_frame>
    <description>Length of hospital stay since admission for current episode of GIB.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">435</enrollment>
  <condition>Gastro Intestinal Bleeding</condition>
  <condition>Upper Gastrointestinal Bleeding</condition>
  <arm_group>
    <arm_group_label>Azithromycin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Metoclopramide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Azithromycin Injection</intervention_name>
    <description>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.</description>
    <arm_group_label>Azithromycin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metoclopramide Injectable Solution</intervention_name>
    <description>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.</description>
    <arm_group_label>Metoclopramide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium chloride 0.9%</intervention_name>
    <description>Normal saline is used as a placebo control.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Adult patients ≥ 18 years of age at the time of presentation;&#xD;
&#xD;
          -  2. Admitted to Rhode Island Hospital (RIH) emergency room or inpatient services;&#xD;
&#xD;
          -  3. Presented with hematemesis, coffee ground emesis, or melena;&#xD;
&#xD;
          -  4. Upper endoscopy is planned within 24 hours of presentation or onset of bleeding.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Known anaphylactic allergic reaction to erythromycin, azithromycin, and/or&#xD;
             metoclopramide;&#xD;
&#xD;
          -  2. Concurrent use of certain medications associated with tardive dyskinesia (TD):&#xD;
&#xD;
          -  a. Fluphenazine,&#xD;
&#xD;
          -  b. Haloperidol,&#xD;
&#xD;
          -  c. Loxapine,&#xD;
&#xD;
          -  d. Paliperidone,&#xD;
&#xD;
          -  e. Perphenazine,&#xD;
&#xD;
          -  f. Pimozide,&#xD;
&#xD;
          -  g. Risperidone,&#xD;
&#xD;
          -  h. Thiothixene,&#xD;
&#xD;
          -  i. Trifluoperazine;&#xD;
&#xD;
          -  3. Concurrent use of certain medications associated with torsade de pointes:&#xD;
&#xD;
          -  a. Amiodarone,&#xD;
&#xD;
          -  b. Chlorpromazine,&#xD;
&#xD;
          -  c. Disopyramide,&#xD;
&#xD;
          -  d. Dofetilide,&#xD;
&#xD;
          -  e. Methadone,&#xD;
&#xD;
          -  f. Procainamide,&#xD;
&#xD;
          -  g. Quinidine,&#xD;
&#xD;
          -  h. Sotalol;&#xD;
&#xD;
          -  4. Known history of TD, ventricular arrhythmias , or long QT syndrome;&#xD;
&#xD;
          -  5. Already received erythromycin and/or azithromycin within the past 10 days, or&#xD;
             metoclopramide within the past 4 days for other indications;&#xD;
&#xD;
          -  6. Recipient of hematopoietic stem cell transplant;&#xD;
&#xD;
          -  7. History of Neisseria gonorrhoeae infection;&#xD;
&#xD;
          -  8. Pregnancy;&#xD;
&#xD;
          -  9. Prior gastrectomy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Waihong Chung, MD PhD</last_name>
    <phone>401-444-5280</phone>
    <email>waihong.chung@lifespan.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Rhode Island Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02906</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Waihong Chung, MD, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>26417980</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22310222</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21278804</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21103422</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19924535</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22364597</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>August 5, 2020</last_update_submitted>
  <last_update_submitted_qc>August 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Lifespan</investigator_affiliation>
    <investigator_full_name>Waihong Chung</investigator_full_name>
    <investigator_title>Fellow</investigator_title>
  </responsible_party>
  <keyword>GIB</keyword>
  <keyword>UGIB</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastrointestinal Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Azithromycin</mesh_term>
    <mesh_term>Metoclopramide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03840057
org study id: 1
nct id: NCT03840057
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
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.
allocation: Randomized
intervention model: Sequential Assignment
intervention 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.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Initial management of UGIB would be performed by the primary team without interference from the investigator. If a gastroenterology consult were placed by the primary team, the endoscopist on-call would evaluate the patient per routine care. If an early endoscopy is deemed appropriate and necessary based on the patient's clinical status, the participant is registered to a central electronic database, which would assign participants to the intervention arm or the placebo arm using a permuted block randomization process. The appropriate medication or placebo is prepared and distributed by the central inpatient pharmacy. The investigator, the endoscopist, the study participant, and the primary team are all blinded to the assignment.
measure: Rate of Reduction in the Need for Second Endoscopy
time frame: 48 hours
description: 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.
measure: Adverse Cardiac Side Effects related to Intervention
time frame: 5 days
description: 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.
measure: Adverse Infectious Disease Side Effects related to Intervention
time frame: 30 days
description: The primary infectious disease outcome measure is the incidence of C. difficile infection, occurring within 30 days of azithromycin administration.
measure: Adverse Neurological Side Effects related to Intervention
time frame: 48 hours
description: 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.
measure: Quality of Endoscopic Visualization
time frame: 48 hours
description: 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.
measure: All-Cause Mortality
time frame: 30 days.
description: All-Cause Mortality within 30 days.
measure: Number of Unit of Transfusion
time frame: 30 days
description: Number of units of packed red blood cells transfused before hemostasis has been achieved or death.
measure: Length of Hospital Stay
time frame: 30 days
description: Length of hospital stay since admission for current episode of GIB.
arm group label: Azithromycin
arm group type: Experimental
description: 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.
arm group label: Metoclopramide
arm group type: Experimental
description: 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.
arm group label: Placebo
arm group type: Placebo Comparator
description: 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.
intervention type: Drug
intervention name: Azithromycin Injection
description: 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.
arm group label: Azithromycin
intervention type: Drug
intervention name: Metoclopramide Injectable Solution
description: 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.
arm group label: Metoclopramide
intervention type: Drug
intervention name: Sodium chloride 0.9%
description: Normal saline is used as a placebo control.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Waihong Chung, MD PhD
phone: 401-444-5280
email: waihong.chung@lifespan.org
facility: 
status: Recruiting
contact: 
country: United States
citation: 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.
PMID: 26417980
citation: 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.
PMID: 22310222
citation: 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.
PMID: 21278804
citation: 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.
PMID: 21103422
citation: 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.
PMID: 19924535
citation: 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.
PMID: 22364597
responsible party type: Sponsor-Investigator
investigator affiliation: Lifespan
investigator full name: Waihong Chung
investigator title: Fellow
mesh term: Gastrointestinal Hemorrhage
mesh term: Hemorrhage
mesh term: Azithromycin
mesh term: Metoclopramide
sharing ipd: Undecided