- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03749590
Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis. (MagPEP)
Prospective Randomized Controlled Phase III Trial to Investigate the Efficacy of Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Mecklenburg-Vorpommern
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Greifswald, Mecklenburg-Vorpommern, Germany, 17475
- Klinik für Innere Medizin A, Universitätsmedizin Greifswald
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
- intake of calcium antagonists
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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). |
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 Names:
|
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 . |
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
reduction in the incidence of post-ERCP pancreatitis by 50 %
Time Frame: 24 hours after ERCP
|
24 hours after ERCP
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
Time Frame: from end of ERCP to discharge from hospital; assessed on day 30 after ERCP
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from end of ERCP to discharge from hospital; assessed on day 30 after ERCP
|
reduction in premature protease activation
Time Frame: during treatment period, assessed 24 h after ERCP
|
during treatment period, assessed 24 h after ERCP
|
reduction in severity of post-ERCP pancreatitis
Time Frame: from 24 hours after ERCP onwards, assessed on day 30 after ERCP
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from 24 hours after ERCP onwards, assessed on day 30 after ERCP
|
reduction in 30-day morbidity
Time Frame: 30 days after ERCP
|
30 days after ERCP
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pancreatic Diseases
- Pancreatitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Magnesium Sulfate
Other Study ID Numbers
- MagPEP
- 2009-013294-18 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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