EUROPAC-2 - Pain Treatment of Hereditary and Idiopathic Pancreatitis

NCT00142233 | Completed Phase 3

• 1 other identifier: EUROPAC-2
• Study Type: interventional
• Target: 295
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreatitis

Keywords

EUROPAC 2, ANTOX (vers)1.2, MGCT (Magnesiocard); Hereditary Pancreatitis; idiopathic chronic pancreatitis

Outcome Measures

Primary Outcomes (1)

• Reduction in the number of days of pancreatic pain.

  1 year

Secondary Outcomes (9)

• Disruption of activities of normal living (patient reports).

  1 year

• Analgesic use for pancreatic pain.

  1 year

• Number of days of hospitalisation for conditions related to pancreatitis.

  1 year

• Quality of life (QoL) measures.

  1 year

• Markers of inflammatory response and activity of the pancreas.

  1 year

Study Arms (3)

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.

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.

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.

Other: Placebo ANTOX (vers)1.2; Other: Placebo Magnesiocard (2.5 mmol)

Interventions

ANTOX (vers.)1.2 DIETARY_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)

ANTOX (vers.)1.2

Magnesium DRUG

15 mmol per day (for patients of 10 years and older) 7,5 mmol per day (for patients aged between 5 and 9 years)

Also known as: Magnesiocard (MGCT)

Magnesium

Placebo ANTOX (vers)1.2 OTHER

Placebo ANTOX (vers)1.2

Magnesium; Placebo

Placebo Magnesiocard (2.5 mmol) OTHER

Placebo Magnesiocard (2.5 mmol)

ANTOX (vers.)1.2; Placebo

Eligibility Criteria

• Age: 5 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medicine Greifswald: lead

Related Links

• Department of Medicine A; Universitätsmedizin Greifswald

MeSH Terms

Conditions

Pancreatitis; Hereditary pancreatitis

Interventions

Magnesium; Aspartic Acid

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Excitatory Amino Acids

Study Officials

• Markus M Lerch, Professor,MD

  Klinik für Innere Medizin A, Universitätsmedizin Greifswald

  PRINCIPAL INVESTIGATOR

• Julia V Mayerle, Professor,MD

  Medizinische Klinik II, Klinikum der Universität München

  PRINCIPAL INVESTIGATOR

• Christopher Halloran, Professor,MD,FRCS

  Molecular and Clinical Cancer Medicine, University of Liverpool

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2005
• First Posted: September 2, 2005
• Study Start: June 6, 2005
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: March 27, 2020

Record last verified: 2020-03