<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/NCT03749590</url>
  </required_header>
  <id_info>
    <org_study_id>MagPEP</org_study_id>
    <secondary_id>2009-013294-18</secondary_id>
    <nct_id>NCT03749590</nct_id>
  </id_info>
  <brief_title>Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis.</brief_title>
  <acronym>MagPEP</acronym>
  <official_title>Prospective Randomized Controlled Phase III Trial to Investigate the Efficacy of Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medicine Greifswald</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medicine Greifswald</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      MagPEP is a multi-centre, randomized, phase III, double blind, placebo controlled, parallel&#xD;
      group trial. It evaluates magnesium sulfate for the prevention of post-ERCP pancreatitis.&#xD;
      Adult patients with a medical indication for ERCP are to be randomized (1:1 ratio) to receive&#xD;
      either magnesium sulfate or placebo (NaCl 0,9%) 60 min before and 6 hours after ERCP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Title: prospective, randomized, placebo controlled, phase III trial to evaluate the efficacy&#xD;
      of magnesium sulfate for the prevention of post-ERCP pancreatitis&#xD;
&#xD;
      Study drug: Magnesium sulfate&#xD;
&#xD;
      Indication: post-ERCP pancreatitis&#xD;
&#xD;
      Study design: multi-centre, randomized, phase III, double blind, placebo controlled, parallel&#xD;
      group&#xD;
&#xD;
      Patient population: adult patients with a medical indication for ERCP&#xD;
&#xD;
      Number of patients: 1376 randomized to two equal groups&#xD;
&#xD;
      Treatment: patients receive 2 infusions of 500 ml NaCl 0,9%: the first one 60 min before ERCP&#xD;
      and the second one 6 hours after ERCP. To the infusions 10 ml of either magnesium sulfate or&#xD;
      placebo (NaCl 0,9%) will be added.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The design of the MagPEP trial is no longer in compliance with the current state of science.&#xD;
  </why_stopped>
  <start_date type="Actual">August 27, 2012</start_date>
  <completion_date type="Actual">August 31, 2020</completion_date>
  <primary_completion_date type="Actual">July 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>reduction in the incidence of post-ERCP pancreatitis by 50 %</measure>
    <time_frame>24 hours after ERCP</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>reduction in intake of analgesics</measure>
    <time_frame>during the first 24 hours after ERCP and, if a post-ERCP pancreatitis occurs, until discharge from hospital</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>duration of stay in hospital after ERCP</measure>
    <time_frame>from end of ERCP to discharge from hospital; assessed on day 30 after ERCP</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>reduction in premature protease activation</measure>
    <time_frame>during treatment period, assessed 24 h after ERCP</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>reduction in severity of post-ERCP pancreatitis</measure>
    <time_frame>from 24 hours after ERCP onwards, assessed on day 30 after ERCP</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>reduction in 30-day morbidity</measure>
    <time_frame>30 days after ERCP</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">327</enrollment>
  <condition>Post-ERCP Pancreatitis</condition>
  <arm_group>
    <arm_group_label>Magnesium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive 2 infusions of 500 ml NaCl 0,9%: the first one 60 min before ERCP and the second one 6 hours after ERCP.&#xD;
With each infusion 10 ml magnesium sulfate (4930 mg magnesium sulfate = 20 mmol magnesium) are administered (total dose: 9860 mg magnesium sulfate).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (NaCl 0,9%)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients receive 2 infusions of 500 ml NaCl 0,9%: the first one 60 min before ERCP and the second one 6 hours after ERCP.&#xD;
To each infusion 10 ml NaCl 0.9% (Placebo) will be added .</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Magnesium Sulfate</intervention_name>
    <description>Patients receive 2 infusions (10 ml magnesium sulfate added to 500 ml NaCl 0.9%): the first infusion 60 min before and the second one 6 hours after ERCP</description>
    <arm_group_label>Magnesium</arm_group_label>
    <other_name>Magnesium Sulfate Heptahydrate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (NaCl 0,9%)</intervention_name>
    <description>Patients receive 2 infusions (10 ml NaCl 0.9% added to 500 ml NaCl 0.9%): the first infusion 60 min before and the second one 6 hours after ERCP</description>
    <arm_group_label>Placebo (NaCl 0,9%)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  medical indication for ERCP&#xD;
&#xD;
          -  first ERCP in the Patient&#xD;
&#xD;
          -  signed informed consent forms for ERCP and MagPEP trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  privious ERCP&#xD;
&#xD;
          -  hypersensitivity to study medication or similar substances&#xD;
&#xD;
          -  participation in another clinical trial during the last 4 weeks&#xD;
&#xD;
          -  addictive disorders&#xD;
&#xD;
          -  women who are pregnant or breastfeeding&#xD;
&#xD;
          -  unwillingness or inability to comply with study protocol&#xD;
&#xD;
          -  acute pancreatitis&#xD;
&#xD;
          -  renal insufficiency of stage 4 or higher&#xD;
&#xD;
          -  active hyperthyreosis&#xD;
&#xD;
          -  symptomatic bradycardia (&lt;35/min)&#xD;
&#xD;
          -  known history of Myasthenia gravis&#xD;
&#xD;
          -  AV bock &gt; first degree or other bradycardic disorders of conductivity&#xD;
&#xD;
          -  liver cirrhosis Child C&#xD;
&#xD;
          -  coagulation disorder&#xD;
&#xD;
          -  urinary stone diathesis (calcium magnesium ammonium phosphate stones)&#xD;
&#xD;
          -  patients who are not able to provide informed consent&#xD;
&#xD;
          -  intake of magnesium during the last 14 days&#xD;
&#xD;
          -  intake of calcium antagonists&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Klinik für Innere Medizin A, Universitätsmedizin Greifswald</name>
      <address>
        <city>Greifswald</city>
        <state>Mecklenburg-Vorpommern</state>
        <zip>17475</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>November 12, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>April 28, 2021</last_update_submitted>
  <last_update_submitted_qc>April 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>MagPEP, post-ERCP pancreatitis, Magnesium Sulfate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Magnesium Sulfate</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03749590
org study id: MagPEP
secondary id: 2009-013294-18
nct id: NCT03749590
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
MagPEP is a multi-centre, randomized, phase III, double blind, placebo controlled, parallel
      group trial. It evaluates magnesium sulfate for the prevention of post-ERCP pancreatitis.
      Adult patients with a medical indication for ERCP are to be randomized (1:1 ratio) to receive
      either magnesium sulfate or placebo (NaCl 0,9%) 60 min before and 6 hours after ERCP.
Title: prospective, randomized, placebo controlled, phase III trial to evaluate the efficacy
      of magnesium sulfate for the prevention of post-ERCP pancreatitis

      Study drug: Magnesium sulfate

      Indication: post-ERCP pancreatitis

      Study design: multi-centre, randomized, phase III, double blind, placebo controlled, parallel
      group

      Patient population: adult patients with a medical indication for ERCP

      Number of patients: 1376 randomized to two equal groups

      Treatment: patients receive 2 infusions of 500 ml NaCl 0,9%: the first one 60 min before ERCP
      and the second one 6 hours after ERCP. To the infusions 10 ml of either magnesium sulfate or
      placebo (NaCl 0,9%) will be added.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: reduction in the incidence of post-ERCP pancreatitis by 50 %
time frame: 24 hours after ERCP
measure: reduction in intake of analgesics
time frame: during the first 24 hours after ERCP and, if a post-ERCP pancreatitis occurs, until discharge from hospital
measure: duration of stay in hospital after ERCP
time frame: from end of ERCP to discharge from hospital; assessed on day 30 after ERCP
measure: reduction in premature protease activation
time frame: during treatment period, assessed 24 h after ERCP
measure: reduction in severity of post-ERCP pancreatitis
time frame: from 24 hours after ERCP onwards, assessed on day 30 after ERCP
measure: reduction in 30-day morbidity
time frame: 30 days after ERCP
arm group label: Magnesium
arm group type: Experimental
description: Patients receive 2 infusions of 500 ml NaCl 0,9%: the first one 60 min before ERCP and the second one 6 hours after ERCP.
With each infusion 10 ml magnesium sulfate (4930 mg magnesium sulfate = 20 mmol magnesium) are administered (total dose: 9860 mg magnesium sulfate).
arm group label: Placebo (NaCl 0,9%)
arm group type: Placebo Comparator
description: Patients receive 2 infusions of 500 ml NaCl 0,9%: the first one 60 min before ERCP and the second one 6 hours after ERCP.
To each infusion 10 ml NaCl 0.9% (Placebo) will be added .
intervention type: Drug
intervention name: Magnesium Sulfate
description: Patients receive 2 infusions (10 ml magnesium sulfate added to 500 ml NaCl 0.9%): the first infusion 60 min before and the second one 6 hours after ERCP
arm group label: Magnesium
other name: Magnesium Sulfate Heptahydrate
intervention type: Drug
intervention name: Placebo (NaCl 0,9%)
description: Patients receive 2 infusions (10 ml NaCl 0.9% added to 500 ml NaCl 0.9%): the first infusion 60 min before and the second one 6 hours after ERCP
arm group label: Placebo (NaCl 0,9%)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Pancreatitis
mesh term: Magnesium Sulfate