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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-013294-18 | EudraCT Number |
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The design of the MagPEP trial is no longer in compliance with the current state of science.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium | Experimental | 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). |
|
| Placebo (NaCl 0,9%) | Placebo Comparator | 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 . |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Sulfate | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| reduction in the incidence of post-ERCP pancreatitis by 50 % | 24 hours after ERCP |
| Measure | Description | Time Frame |
|---|---|---|
| reduction in intake of analgesics | 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 | from end of ERCP to discharge from hospital; assessed on day 30 after ERCP |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Innere Medizin A, Universitätsmedizin Greifswald | Greifswald | Mecklenburg-Vorpommern | 17475 | Germany |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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| Placebo (NaCl 0,9%) | Drug | 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 |
|
| reduction in premature protease activation | during treatment period, assessed 24 h after ERCP |
| reduction in severity of post-ERCP pancreatitis | from 24 hours after ERCP onwards, assessed on day 30 after ERCP |
| reduction in 30-day morbidity | 30 days after ERCP |
| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |