Post-ERCP PancreatitisPhase 3MagPEPNCT03749590
Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis.
A Phase 3 study testing Magnesium Sulfate in people with Post-ERCP Pancreatitis, run by University Medicine Greifswald at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-ERCP Pancreatitis
- What is being tested?
- Magnesium Sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 327 participants
- Where
- 1 siteGermany
- Study dates
- 27 Aug 2012to 31 Aug 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- medical indication for ERCP
- first ERCP in the Patient
- signed informed consent forms for ERCP and MagPEP trial
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik für Innere Medizin A, Universitätsmedizin Greifswald
Greifswald, Mecklenburg-Vorpommern, 17475
About this study
Official title: Prospective Randomized Controlled Phase III Trial to Investigate the Efficacy of Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis.
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.
Read the 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.
- Conditions
- Post-ERCP Pancreatitis
- Being tested
- Magnesium Sulfate, Placebo (NaCl 0,9%)
- Keywords
- MagPEP, post-ERCP pancreatitis, Magnesium Sulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
Also called Magnesium Sulfate Heptahydrate
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
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: 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 . Receives: Drug: Placebo (NaCl 0,9%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in the incidence of post-ERCP pancreatitis by 50 %
Measured: 24 hours after ERCP
Secondary outcomes (5)
reduction in intake of analgesics
Measured: 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
Measured: from end of ERCP to discharge from hospital; assessed on day 30 after ERCP
reduction in premature protease activation
Measured: during treatment period, assessed 24 h after ERCP
reduction in severity of post-ERCP pancreatitis
Measured: from 24 hours after ERCP onwards, assessed on day 30 after ERCP
reduction in 30-day morbidity
Measured: 30 days after ERCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start27 Aug 2012
- Primary completionJul 2020
- Study completion31 Aug 2020
Why it stopped: The design of the MagPEP trial is no longer in compliance with the current state of science.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-ERCP PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749590
- Sponsor's protocol ID
- MagPEP
- Other IDs
- 2009-013294-18, 2009
- Acronym
- MagPEP
- Status last verified
- Apr 2021
- First submitted
- 12 Nov 2018
- Last updated
- 3 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Phase III Trial to Investigate the Efficacy of Magnesium Sulfate in the Prevention of Post-ERCP Pancreatitis.
- ClinicalTrials.gov ID
- NCT03749590
- Acronym / sponsor ID
- MagPEP / MagPEP
- Conditions
- Post-ERCP Pancreatitis
- Keywords
- MagPEP, post-ERCP pancreatitis, Magnesium Sulfate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The design of the MagPEP trial is no longer in compliance with the current state of science.
- Enrolment
- 327 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- 27 Aug 2012 (actual)
- Primary completion
- Jul 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 21 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium | Experimental | Drug: Magnesium SulfatePatients 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 | Drug: 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 . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- medical indication for ERCP
- first ERCP in the Patient
- signed informed consent forms for ERCP and MagPEP trial
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium SulfateAlso: Magnesium Sulfate HeptahydratePatients 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 | Drug | Magnesium |
| 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 | Drug | Placebo (NaCl 0,9%) |
Primary outcome
reduction in the incidence of post-ERCP pancreatitis by 50 %
Time frame: 24 hours after ERCP
5 secondary outcomes
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
duration of stay in hospital after ERCP
Time frame: 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
reduction in severity of post-ERCP pancreatitis
Time frame: from 24 hours after ERCP onwards, assessed on day 30 after ERCP
reduction in 30-day morbidity
Time frame: 30 days after ERCP
Results and safety
The study was stopped early (reason given: The design of the MagPEP trial is no longer in compliance with the current state of science.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Magnesium Sulfate in people with Post-ERCP Pancreatitis, run by University Medicine Greifswald at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The design of the MagPEP trial is no longer in compliance with the current state of science.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction in the incidence of post-ERCP pancreatitis by 50 % (time frame: 24 hours after ERCP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.