Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT00142233
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.
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:
NCT00142233
Study Brief:
Protocol Section:
NCT00142233