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Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis.

NCT03749590 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 327

Last updated 2021-05-03

No results posted yet for this study

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.

Conditions

  • Post-ERCP Pancreatitis

Interventions

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

Sponsors & Collaborators

  • University Medicine Greifswald

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-27
Primary Completion
2020-07-31
Completion
2020-08-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03749590 on ClinicalTrials.gov