EUROPAC-2 - Pain Treatment of Hereditary & Idiopathic Pancreatitis

Status Completed

Clinical 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.

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.

Clinical Trial 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

Related Conditions & MeSH terms

Pancreatitis

Clinical Trial Details

NCT number	NCT00142233
Study type	Interventional
Source	University Medicine Greifswald
Contact
Status	Completed
Phase	Phase 3
Start date	June 6, 2005
Completion date	September 2019

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

EUROPAC-2 - Pain Treatment of Hereditary and Idiopathic Pancreatitis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms