NCT03749590

Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis.

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 327 (actual)
• Sponsor: University Medicine Greifswald · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Post-ERCP Pancreatitis

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2012-08-27
• Primary completion: 2020-07-01
• Completion: 2020-08-31
• First posted: 2018-11-21
• Last updated: 2021-05-03

Locations

1 site across 1 country: Germany