Magnesiumsulfate in the prevention of post-ERCP pancreatitis – a prospective randomized, placebo-controlled multicenter study - MagPEP

Phase 1

• Conditions: Post-ERCP pancreatitis

• Registration Number: EUCTR2009-013294-18-DE
• Lead Sponsor: niversitätsklinikum Greifswald der Ernst-Moritz-Arndt Universität Greifswald AöR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-02
• Last Update Posted: 28 September 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 502

Inclusion Criteria

Adult (= 18 years of age) patients (male and female) with a medical indication for a diagnostic or therapeutic endoscopic retrograde cholangiopancreatography (ERCP).
Written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Known allergy or intolerance to one of the medicaments utilized in the study or their ingredients

Participation in another clinical study during the previous four weeks

Pregnancy and breast feeding

Acute pancreatitis

Renal insufficiency = stadium 4 (K/DOQI)

Hyperthyreoidism

Symptomatic Bradycardia <35 bpm

Atrioventricular block > 1° or other cardial conduction defects

Myasthenia gravis

Liver cirrhosis Child C

Any apparent coagulopathy

Kidney stone diathesis (calcium-magnesium-ammonium-phosphate stones)

Mental impairment, addicitve or other disorders leading to the patients inability to understand the scope and possible consequences of a participation in the clinical trial

Magnesium medication within 14 days before the procedure

Inability to give informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified