EUROPAC-2 - Pain Treatment of Hereditary and Idiopathic Pancreatitis

Plain-language summary

This study examines antioxidant (ANTOX) and magnesium treatments compared with placebo for reducing pain in patients with hereditary or idiopathic chronic pancreatitis. It enrolled patients aged 5 to 75 who had had pancreatitis symptoms for at least a year and either carried a mutation in the PRSS1 gene or had idiopathic pancreatitis. The research was conducted in Phase 3 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Completed

Sponsor

University Medicine Greifswald

Intervention

ANTOX (vers.)1.2, Magnesium, Placebo ANTOX (vers)1.2, Placebo Magnesiocard (2.5 mmol)

Start date

6/6/2005

Estimated completion

9/1/2019

Related genes

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.