search
Back to results

EUROPAC-2 - Pain Treatment of Hereditary and Idiopathic Pancreatitis

Primary Purpose

Pancreatitis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ANTOX (vers.)1.2
Magnesium
Placebo ANTOX (vers)1.2
Placebo Magnesiocard (2.5 mmol)
Sponsored by
University Medicine Greifswald
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatitis focused on measuring EUROPAC 2, ANTOX (vers)1.2, MGCT (Magnesiocard), Hereditary Pancreatitis, idiopathic chronic pancreatitis

Eligibility Criteria

5 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients must have had symptoms of pancreatitis for at least one year. Patients must be willing to be followed up regularly for at least one year. Patients aged 5 to 75 years of age. Individuals must have characteristic pancreatic pain that is either intermittent or continuous (2 or more episodes during the last 12 months) Patients with documented Hereditary Pancreatitis (HP), clinically defined or proven by gene mutations in the PRSS1 Gene, or patients with Idiopathic Chronic Pancreatitis (ICP) and no mutations detected in the PRSS1 gene. This may include patients with a history of alcohol intake who have been abstinent for at least 24 month. Exclusion Criteria: Patients that do not consent to be involved in the trial, or whose parents do not consent for their children to be involved. Patients or guardians of underage patients, with learning disabilities or other cognitive or sensory impairments that would prevent adequate understanding of the study requirements. Patients who have had recent treatment (<3 months), or are currently receiving treatment with antioxidants or magnesium tablets. Patients who have had recent (<3 months), or are currently receiving treatment with oral steroids for their pancreatic disease. Patients with renal failure (serum creatinine 200 µg/l). Patients with atrio-ventricular-block. Serum triglyceride levels >= 1000 mg/dl. Patients under the age of five years or over the age of 75 years. Patients who are dependent on daily opiate analgesia (morphine or equivalent) for more than 12 months. Patients who have chronic hepatic failure, or serious impairment of pulmonary, cardiac, neurological or cerebral function. Patients who are participating in another drug trial. Patients who are pregnant. Women of childbearing age who are not using contraception. Lactating mothers. Any disorder that would prevent adequate absorption of the active treatment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    ANTOX (vers.)1.2

    Magnesium

    Placebo

    Arm Description

    Adults and children aged 10+ will take two ANTOX (vers)1.2 tablets three times per day. (Antioxidant treatment: daily: 300 μg organic selenium, 720 mg vitamin C, 228 mg vitamin E, 2880 mg methionine) plus two placebo Magnesiocard (2.5 mmol) tablets three times per day. Children aged five to nine years of age will take one ANTOX (vers)1.2 tablet three times daily (Antioxidant treatment: daily: 150 μg organic selenium, 360 mg vitamin C, 114 mg vitamin E, 1440 mg methionine) plus one placebo Magnesiocard (2.5 mmol) tablet three times a day.

    Adults and children aged 10+ will take two Magnesiocard (2.5 mmol) tablets three times per day (total dose: 15 mmol = 365 mg per day) plus two placebo ANTOX (vers)1.2 tablets three times a day. Children aged five to nine years of age will take one Magnesiocard (2.5 mmol) tablet three times a day (total dose: 7.5 mmol = 182 mg per day) plus one placebo ANTOX (vers)1.2 tablet three times a day.

    Adults and children aged 10+ will take two placebo ANTOX (vers)1.2 tablets three times a day, plus two placebo Magnesiocard (2.5 mmol) tablets three times per day. Children aged five to nine years of age will take one placebo ANTOX (vers)1.2 tablet three times a day, plus one placebo Magnesiocard (2.5 mmol) tablet three times per day.

    Outcomes

    Primary Outcome Measures

    Reduction in the number of days of pancreatic pain.

    Secondary Outcome Measures

    Disruption of activities of normal living (patient reports).
    Number of days with limitations in activities by pancreatic pain per week, Assessment of limitation in activities by pancreatic pain (scale from 0 (no limitation) to 10 (total limitation))
    Analgesic use for pancreatic pain.
    Number of days of hospitalisation for conditions related to pancreatitis.
    Quality of life (QoL) measures.
    Markers of inflammatory response and activity of the pancreas.
    Changes in urinary levels of magnesium, selenium, and vitamin C.
    Antioxidant response as measured by urinary thiobarbituric acid levels.
    Response in patients with hereditary pancreatitis and idiopathic chronic pancreatitis.
    Correlate response with gene mutations underlying hereditary pancreatitis (PRSS1, other) and idiopathic chronic pancreatitis (SPINK1, Cystic Fibrosis Transmembrane Conductance Regulator (CFTR), other).

    Full Information

    First Posted
    August 31, 2005
    Last Updated
    March 25, 2020
    Sponsor
    University Medicine Greifswald
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00142233
    Brief Title
    EUROPAC-2 - Pain Treatment of Hereditary and Idiopathic Pancreatitis
    Official Title
    Double Blind Randomised Controlled Trial to Investigate the Efficacy of ANTOX (Vers) 1.2 and MGCT (Magnesiocard) for the Treatment of Hereditary Pancreatitis and Idiopathic Chronic Pancreatitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    June 6, 2005 (Actual)
    Primary Completion Date
    September 2019 (Actual)
    Study Completion Date
    September 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Medicine Greifswald

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This is a multi-centre randomised phase III, double blind, placebo controlled, parallel group, outpatient study in patients diagnosed with hereditary pancreatitis and idiopathic chronic pancreatitis. The hypothesis to be tested is a 30% reduction in the number of days due to pancreatitis from 12.5 days per year to less than nine days per year under the treatment with magnesium or an antioxidant cocktail called ANTOX. A total of 288 patients will be randomised to one of three treatment groups in order to compare pancreatic pain over a twelve month period.
    Detailed Description
    Title: EUROPAC 2 trial to investigate the efficacy of ANTOX (vers) 1.2 and MGCT (Magnesiocard) for the treatment of hereditary pancreatitis and idiopathic chronic pancreatitis Study drug: ANTOX (vers) 1.2, MGCT (Magnesiocard) Intended indication: Hereditary pancreatitis and idiopathic chronic pancreatitis Study design: A multi-centre, double blind, and placebo-controlled, randomised, parallel group study Patient population: Patients with hereditary pancreatitis or idiopathic chronic pancreatitis Number of patients: Total of 288 patients in three equal groups Proposed number of initial centres: two (Greifswald, Germany and Liverpool, UK). Duration of dosing: 12 months Treatment groups: Group one: Two ANTOX (vers) 1.2 tablets, three times daily, Antioxidant treatment: 300 µg organic selenium, 720 mg vitamin C, 228 mg vitamin E, 2880 mg methionine per day. Group two: Two Magnesium-L-Aspartate-hydrochloride (Magnesiocard 2,5 mmol (MGCT)) tablets, three times daily, total dose 15 mmol (365 mg) per day. Group three: The same number of tablets as in Groups one and two but placebo instead of active drug. Efficacy parameters: Primary: Pain (number of days of pancreatic pain) Secondary: Severity of pain; analgesic use for pancreatic pain; number of days of hospitalisation for conditions related to chronic pancreatitis; quality of life; markers of inflammatory response, antioxidant response, changes in urinary levels of magnesium, selenium, vitamin C and activity of the pancreatitis and pancreatic function. Safety parameters: Toxicity; Adverse events

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pancreatitis
    Keywords
    EUROPAC 2, ANTOX (vers)1.2, MGCT (Magnesiocard), Hereditary Pancreatitis, idiopathic chronic pancreatitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    295 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ANTOX (vers.)1.2
    Arm Type
    Experimental
    Arm Description
    Adults and children aged 10+ will take two ANTOX (vers)1.2 tablets three times per day. (Antioxidant treatment: daily: 300 μg organic selenium, 720 mg vitamin C, 228 mg vitamin E, 2880 mg methionine) plus two placebo Magnesiocard (2.5 mmol) tablets three times per day. Children aged five to nine years of age will take one ANTOX (vers)1.2 tablet three times daily (Antioxidant treatment: daily: 150 μg organic selenium, 360 mg vitamin C, 114 mg vitamin E, 1440 mg methionine) plus one placebo Magnesiocard (2.5 mmol) tablet three times a day.
    Arm Title
    Magnesium
    Arm Type
    Experimental
    Arm Description
    Adults and children aged 10+ will take two Magnesiocard (2.5 mmol) tablets three times per day (total dose: 15 mmol = 365 mg per day) plus two placebo ANTOX (vers)1.2 tablets three times a day. Children aged five to nine years of age will take one Magnesiocard (2.5 mmol) tablet three times a day (total dose: 7.5 mmol = 182 mg per day) plus one placebo ANTOX (vers)1.2 tablet three times a day.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Adults and children aged 10+ will take two placebo ANTOX (vers)1.2 tablets three times a day, plus two placebo Magnesiocard (2.5 mmol) tablets three times per day. Children aged five to nine years of age will take one placebo ANTOX (vers)1.2 tablet three times a day, plus one placebo Magnesiocard (2.5 mmol) tablet three times per day.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    ANTOX (vers.)1.2
    Intervention Description
    300 µg organic selenium, 720 mg vitamin C, 228 mg vitamin E, 2880 mg methionine per day (for patients of 10 years and older) 150 µg organic selenium, 360 mg vitamin C, 114 mg vitamin E, 1440 mg methionine per day (for patients aged between 5 and 9 years)
    Intervention Type
    Drug
    Intervention Name(s)
    Magnesium
    Other Intervention Name(s)
    Magnesiocard (MGCT)
    Intervention Description
    15 mmol per day (for patients of 10 years and older) 7,5 mmol per day (for patients aged between 5 and 9 years)
    Intervention Type
    Other
    Intervention Name(s)
    Placebo ANTOX (vers)1.2
    Intervention Description
    Placebo ANTOX (vers)1.2
    Intervention Type
    Other
    Intervention Name(s)
    Placebo Magnesiocard (2.5 mmol)
    Intervention Description
    Placebo Magnesiocard (2.5 mmol)
    Primary Outcome Measure Information:
    Title
    Reduction in the number of days of pancreatic pain.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Disruption of activities of normal living (patient reports).
    Description
    Number of days with limitations in activities by pancreatic pain per week, Assessment of limitation in activities by pancreatic pain (scale from 0 (no limitation) to 10 (total limitation))
    Time Frame
    1 year
    Title
    Analgesic use for pancreatic pain.
    Time Frame
    1 year
    Title
    Number of days of hospitalisation for conditions related to pancreatitis.
    Time Frame
    1 year
    Title
    Quality of life (QoL) measures.
    Time Frame
    1 year
    Title
    Markers of inflammatory response and activity of the pancreas.
    Time Frame
    1 year
    Title
    Changes in urinary levels of magnesium, selenium, and vitamin C.
    Time Frame
    1 year
    Title
    Antioxidant response as measured by urinary thiobarbituric acid levels.
    Time Frame
    1 year
    Title
    Response in patients with hereditary pancreatitis and idiopathic chronic pancreatitis.
    Time Frame
    1 year
    Title
    Correlate response with gene mutations underlying hereditary pancreatitis (PRSS1, other) and idiopathic chronic pancreatitis (SPINK1, Cystic Fibrosis Transmembrane Conductance Regulator (CFTR), other).
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients must have had symptoms of pancreatitis for at least one year. Patients must be willing to be followed up regularly for at least one year. Patients aged 5 to 75 years of age. Individuals must have characteristic pancreatic pain that is either intermittent or continuous (2 or more episodes during the last 12 months) Patients with documented Hereditary Pancreatitis (HP), clinically defined or proven by gene mutations in the PRSS1 Gene, or patients with Idiopathic Chronic Pancreatitis (ICP) and no mutations detected in the PRSS1 gene. This may include patients with a history of alcohol intake who have been abstinent for at least 24 month. Exclusion Criteria: Patients that do not consent to be involved in the trial, or whose parents do not consent for their children to be involved. Patients or guardians of underage patients, with learning disabilities or other cognitive or sensory impairments that would prevent adequate understanding of the study requirements. Patients who have had recent treatment (<3 months), or are currently receiving treatment with antioxidants or magnesium tablets. Patients who have had recent (<3 months), or are currently receiving treatment with oral steroids for their pancreatic disease. Patients with renal failure (serum creatinine 200 µg/l). Patients with atrio-ventricular-block. Serum triglyceride levels >= 1000 mg/dl. Patients under the age of five years or over the age of 75 years. Patients who are dependent on daily opiate analgesia (morphine or equivalent) for more than 12 months. Patients who have chronic hepatic failure, or serious impairment of pulmonary, cardiac, neurological or cerebral function. Patients who are participating in another drug trial. Patients who are pregnant. Women of childbearing age who are not using contraception. Lactating mothers. Any disorder that would prevent adequate absorption of the active treatment.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Markus M Lerch, Professor,MD
    Organizational Affiliation
    Klinik für Innere Medizin A, Universitätsmedizin Greifswald
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Julia V Mayerle, Professor,MD
    Organizational Affiliation
    Medizinische Klinik II, Klinikum der Universität München
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Christopher Halloran, Professor,MD,FRCS
    Organizational Affiliation
    Molecular and Clinical Cancer Medicine, University of Liverpool
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://www.pancreas.de
    Description
    Department of Medicine A; Universitätsmedizin Greifswald

    Learn more about this trial

    EUROPAC-2 - Pain Treatment of Hereditary and Idiopathic Pancreatitis

    We'll reach out to this number within 24 hrs