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

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ClinicalTrials.gov Identifier: NCT03749590
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
University Medicine Greifswald

Brief 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.

Condition or disease Intervention/treatment Phase
Post-ERCP Pancreatitis Drug: Magnesium Sulfate Drug: Placebo (NaCl 0,9%) Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1376 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prospective Randomized Controlled Phase III Trial to Investigate the Efficacy of Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis.
Actual Study Start Date : August 27, 2012
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

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 Name: 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




Primary Outcome Measures :
  1. reduction in the incidence of post-ERCP pancreatitis by 50 % [ Time Frame: 24 hours after ERCP ]

Secondary Outcome Measures :
  1. 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 ]
  2. duration of stay in hospital after ERCP [ Time Frame: from end of ERCP to discharge from hospital; assessed on day 30 after ERCP ]
  3. reduction in premature protease activation [ Time Frame: during treatment period, assessed 24 h after ERCP ]
  4. reduction in severity of post-ERCP pancreatitis [ Time Frame: from 24 hours after ERCP onwards, assessed on day 30 after ERCP ]
  5. reduction in 30-day morbidity [ Time Frame: 30 days after ERCP ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749590


Contacts
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Contact: Markus M. Lerch, Prof. Dr. 03834-86 ext 7230 lerch@uni-greifswald.de
Contact: Peter Simon, Dr. 03834-86 ext 6669 peter.simon@uni-greifswald.de

Locations
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Germany
Klinik für Innere Medizin A, Universitätsmedizin Greifswald Recruiting
Greifswald, Mecklenburg-Vorpommern, Germany, 17475
Contact: Markus M. Lerch, Prof. Dr.    03834-86 ext 7230    lerch@uni-greifswald.de   
Contact: Peter Simon, Dr.    03834-86 ext 6669    peter.simon@uni-greifswald.de   
Sponsors and Collaborators
University Medicine Greifswald

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Responsible Party: University Medicine Greifswald
ClinicalTrials.gov Identifier: NCT03749590     History of Changes
Other Study ID Numbers: MagPEP
2009-013294-18 ( EudraCT Number )
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Medicine Greifswald:
MagPEP, post-ERCP pancreatitis, Magnesium Sulfate
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents