Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis. (MagPEP)

April 28, 2021 updated by: University Medicine Greifswald

Prospective Randomized Controlled Phase III Trial to Investigate the Efficacy of Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

327

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Mecklenburg-Vorpommern
      • Greifswald, Mecklenburg-Vorpommern, Germany, 17475
        • Klinik für Innere Medizin A, Universitätsmedizin Greifswald

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • medical indication for ERCP
  • first ERCP in the Patient
  • signed informed consent forms for ERCP and MagPEP trial

Exclusion Criteria:

  • privious ERCP
  • hypersensitivity to study medication or similar substances
  • participation in another clinical trial during the last 4 weeks
  • addictive disorders
  • women who are pregnant or breastfeeding
  • unwillingness or inability to comply with study protocol
  • acute pancreatitis
  • renal insufficiency of stage 4 or higher
  • active hyperthyreosis
  • symptomatic bradycardia (<35/min)
  • known history of Myasthenia gravis
  • AV bock > first degree or other bradycardic disorders of conductivity
  • liver cirrhosis Child C
  • coagulation disorder
  • urinary stone diathesis (calcium magnesium ammonium phosphate stones)
  • patients who are not able to provide informed consent
  • intake of magnesium during the last 14 days
  • intake of calcium antagonists

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnesium

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).
Drug: Magnesium Sulfate
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
Other Names:
  • Magnesium Sulfate Heptahydrate
Placebo Comparator: Placebo (NaCl 0,9%)

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 .
Drug: Placebo (NaCl 0,9%)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
reduction in the incidence of post-ERCP pancreatitis by 50 %
Time Frame: 24 hours after ERCP
24 hours after ERCP

Secondary Outcome Measures

Outcome Measure
Time Frame
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
during the first 24 hours after ERCP and, if a post-ERCP pancreatitis occurs, until discharge from hospital
duration of stay in hospital after ERCP
Time Frame: from end of ERCP to discharge from hospital; assessed on day 30 after ERCP
from end of ERCP to discharge from hospital; assessed on day 30 after ERCP
reduction in premature protease activation
Time Frame: during treatment period, assessed 24 h after ERCP
during treatment period, assessed 24 h after ERCP
reduction in severity of post-ERCP pancreatitis
Time Frame: from 24 hours after ERCP onwards, assessed on day 30 after ERCP
from 24 hours after ERCP onwards, assessed on day 30 after ERCP
reduction in 30-day morbidity
Time Frame: 30 days after ERCP
30 days after ERCP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medicine Greifswald

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2012

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

August 31, 2020

Study Registration Dates

First Submitted

November 12, 2018

First Submitted That Met QC Criteria

November 20, 2018

First Posted (Actual)

November 21, 2018

Study Record Updates

Last Update Posted (Actual)

May 3, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MagPEP
  • 2009-013294-18 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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