PancreatitisPhase 3NCT00142233
EUROPAC-2 - Pain Treatment of Hereditary and Idiopathic Pancreatitis
A Phase 3 study testing ANTOX (vers.)1.2 and Magnesium in people with Pancreatitis, run by University Medicine Greifswald.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 75 years
- Conditions the study is for
- Pancreatitis
- What is being tested?
- ANTOX (vers.)1.2 and Magnesium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 295 participants
- Where
- No sites listed yet
- Study dates
- 6 Jun 2005to Sep 2019
- 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 5 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
About this study
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
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.
Read the 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
- Conditions
- Pancreatitis
- Being tested
- ANTOX (vers.)1.2, Magnesium, Placebo ANTOX (vers)1.2, Placebo Magnesiocard (2.5 mmol)
- Keywords
- EUROPAC 2, ANTOX (vers)1.2, MGCT (Magnesiocard), Hereditary Pancreatitis, idiopathic chronic pancreatitis
- Medical subject headings
- Pancreatitis, Hereditary pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANTOX (vers.)1.2Dietary supplement
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)
MagnesiumDrug
Also called Magnesiocard (MGCT)
15 mmol per day (for patients of 10 years and older)
7,5 mmol per day (for patients aged between 5 and 9 years)
Placebo ANTOX (vers)1.2Other
Placebo ANTOX (vers)1.2
Placebo Magnesiocard (2.5 mmol)Other
Placebo Magnesiocard (2.5 mmol)
| Study group | Role | What they receive |
|---|---|---|
| ANTOX (vers.)1.2 | Experimental | 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. Receives: Dietary Supplement: ANTOX (vers.)1.2; Other: Placebo Magnesiocard (2.5 mmol) |
| Magnesium | Experimental | 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. Receives: Drug: Magnesium; Other: Placebo ANTOX (vers)1.2 |
| Placebo | Placebo comparator | 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. Receives: Other: Placebo ANTOX (vers)1.2; Other: Placebo Magnesiocard (2.5 mmol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the number of days of pancreatic pain.
Measured: 1 year
Secondary outcomes (9)
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))
Measured: 1 year
Analgesic use for pancreatic pain.
Measured: 1 year
Number of days of hospitalisation for conditions related to pancreatitis.
Measured: 1 year
Quality of life (QoL) measures.
Measured: 1 year
Markers of inflammatory response and activity of the pancreas.
Measured: 1 year
Changes in urinary levels of magnesium, selenium, and vitamin C.
Measured: 1 year
Antioxidant response as measured by urinary thiobarbituric acid levels.
Measured: 1 year
Response in patients with hereditary pancreatitis and idiopathic chronic pancreatitis.
Measured: 1 year
Correlate response with gene mutations underlying hereditary pancreatitis (PRSS1, other) and idiopathic chronic pancreatitis (SPINK1, Cystic Fibrosis Transmembrane Conductance Regulator (CFTR), other).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study start6 Jun 2005
- Primary completionSep 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markus M Lerch, Professor,MD, Principal investigator, Klinik für Innere Medizin A, Universitätsmedizin GreifswaldJulia V Mayerle, Professor,MD, Principal investigator, Medizinische Klinik II, Klinikum der Universität MünchenChristopher Halloran, Professor,MD,FRCS, Principal investigator, Molecular and Clinical Cancer Medicine, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00142233
- Sponsor's protocol ID
- EUROPAC-2
- Status last verified
- Mar 2020
- First submitted
- 31 Aug 2005
- Last updated
- 27 Mar 2020
- 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 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00142233
- Acronym / sponsor ID
- EUROPAC-2
- Conditions
- Pancreatitis
- Keywords
- EUROPAC 2, ANTOX (vers)1.2, MGCT (Magnesiocard), Hereditary Pancreatitis, idiopathic chronic pancreatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- 6 Jun 2005 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 2 Sep 2005 (estimated)
- 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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ANTOX (vers.)1.2 | Experimental | Dietary Supplement: ANTOX (vers.)1.2, Other: Placebo Magnesiocard (2.5 mmol)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. |
| Magnesium | Experimental | Drug: Magnesium, Other: Placebo ANTOX (vers)1.2Adults 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. |
| Placebo | Placebo comparator | Other: Placebo ANTOX (vers)1.2, Other: Placebo Magnesiocard (2.5 mmol)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. |
Who may qualify
- Ages
- 5 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
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 |
|---|---|---|
| ANTOX (vers.)1.2300 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) | Dietary supplement | ANTOX (vers.)1.2 |
| MagnesiumAlso: Magnesiocard (MGCT)15 mmol per day (for patients of 10 years and older) 7,5 mmol per day (for patients aged between 5 and 9 years) | Drug | Magnesium |
| Placebo ANTOX (vers)1.2Placebo ANTOX (vers)1.2 | Other | Magnesium, Placebo |
| Placebo Magnesiocard (2.5 mmol)Placebo Magnesiocard (2.5 mmol) | Other | ANTOX (vers.)1.2, Placebo |
Primary outcome
Reduction in the number of days of pancreatic pain.
Time frame: 1 year
9 secondary outcomes
Disruption of activities of normal living (patient reports).
Time frame: 1 year
Analgesic use for pancreatic pain.
Time frame: 1 year
Number of days of hospitalisation for conditions related to pancreatitis.
Time frame: 1 year
Quality of life (QoL) measures.
Time frame: 1 year
Markers of inflammatory response and activity of the pancreas.
Time frame: 1 year
Changes in urinary levels of magnesium, selenium, and vitamin C.
Time frame: 1 year
Antioxidant response as measured by urinary thiobarbituric acid levels.
Time frame: 1 year
Response in patients with hereditary pancreatitis and idiopathic chronic pancreatitis.
Time frame: 1 year
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Department of Medicine A; Universitätsmedizin GreifswaldLink provided by the sponsor.
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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.
Markus M Lerch, Professor,MD principal investigator
Klinik für Innere Medizin A, Universitätsmedizin Greifswald
Julia V Mayerle, Professor,MD principal investigator
Medizinische Klinik II, Klinikum der Universität München
Christopher Halloran, Professor,MD,FRCS principal investigator
Molecular and Clinical Cancer Medicine, University of Liverpool
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ANTOX (vers.)1.2 and Magnesium in people with Pancreatitis, run by University Medicine Greifswald.
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 5 inclusion and 15 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: finished, as of the sponsor's last update on 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 number of days of pancreatic pain. (time frame: 1 year). 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 27 Mar 2020.