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

Post-ERCP Pancreatitis Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03749590
Study type Interventional
Source University Medicine Greifswald
Contact
Status Terminated
Phase Phase 3
Start date August 27, 2012
Completion date August 31, 2020
View Details
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