Status:
TERMINATED
Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis.
Lead Sponsor:
University Medicine Greifswald
Conditions:
Post-ERCP Pancreatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 wit...
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 Indicatio...
Eligibility Criteria
Inclusion
- medical indication for ERCP
- first ERCP in the Patient
- signed informed consent forms for ERCP and MagPEP trial
Exclusion
- 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
Key Trial Info
Start Date :
August 27 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2020
Estimated Enrollment :
327 Patients enrolled
Trial Details
Trial ID
NCT03749590
Start Date
August 27 2012
End Date
August 31 2020
Last Update
May 3 2021
Active Locations (1)
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1
Klinik für Innere Medizin A, Universitätsmedizin Greifswald
Greifswald, Mecklenburg-Vorpommern, Germany, 17475