EUROPAC-2 - Pain Treatment of Hereditary and Idiopathic Pancreatitis

University Medicine Greifswald295 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

Conditions

Pancreatitis

Interventions

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

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

Eligibility

Sex: ALLMin age: 5 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients must have had symptoms of pancreatitis for at least one year. 2. Patients must be willing to be followed up regularly for at least one year. 3. Patients aged 5 to 75 years of age. 4. Individuals must have characteristic pancreatic pain that is either intermittent or continuous (2 or more episodes during the last 12 months) 5. 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: 1. Patients that do not consent to be involved in the trial, or whose parents do not consent for their children to be involved. 2. Patients or guardians of underage patients, with learning disabilities or other cognitive or sensory impairments that would prevent adequate understanding of the study requirements. 3. Patients who have had recent treatment (\<3 months), or are currently receiving treatment with antioxidants or magnesium tablets. 4. Patients who have had recent (\<3 months), or are currently receiving treatment with oral steroids for their pancreatic disease. 5. Patients with renal failure (serum creatinine 200 µg/l). 6. Patients with atrio-ventricular-block. 7. Serum triglyceride levels \>= 1000 mg/dl. 8. Patients under the age of five years or over the age of 75 years. 9. Patients who are dependent on daily opiate analgesia (morphine or equivalent) for more than 12 months. 10. Patients who have chronic hepatic failure, or serious impairment of pulmonary, cardiac, neurological or cerebral function. 11. Patients who are participating in another drug trial. 12. Patients who are pregnant. 13. Women of childbearing age who are not using contraception. 14. Lactating mothers. 15. Any disorder that would prevent adequate absorption of the active treatment.

Outcomes

Primary Outcomes

Reduction in the number of days of pancreatic pain.

Time frame: 1 year

Secondary Outcomes

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))

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

Data from ClinicalTrials.gov

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