Clinical Trial: EUROPAC-2 - Pain Treatment of Hereditary and Idiopathic Pancreatitis

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Double Blind Randomised Controlled Trial to Investigate the Efficacy of ANTOX (Vers) 1.2 and MGCT (Magnesiocard) for the Treatment of Hereditary Pancreatitis and Idiopathi

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 240 patients will be randomised to one of three treatment groups in order to compare pancreatic pain over a twelve month period.


Detailed Summary:

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 240 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: Daily: 300 µg organic selenium, 54000 IU beta carotene = 18 mg, 750 mg vitamin C, 540 IU of vitamin E = 240 mg, 2700 mg methionine.

Group two: Two Magnesium-L-Aspartate-hydrochloride (MGCT) (Magnesiocard  2,5 mmol tablets three times a day, total dose 15 mmol ([365 mg/per day]) tablets.

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)

Secon
Sponsor: University Medicine Greifswald

Current Primary Outcome: Reduction in the number of days of pancreatic pain during 12 continuous months of treatment.

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Disruption of activities of normal living.
  • Analgesic use for pancreatic pain.
  • Number of days of hospitalisation for conditions related to pancreatitis.
  • Quality of life (QoL) measures.
  • Markers of inflammatory response and activity of the pancreas.
  • Changes in urinary levels of magnesium, selenium, and vitamin C over the duration of the study.
  • Antioxidant response as measured by urinary thiobarbituric acid levels.
  • Response in patients with hereditary pancreatitis and idiopathic chronic pancreatitis.
  • Correlate response with gene mutations underlying hereditary pancreatitis (PRSS1, other) and idiopathic chronic pancreatitis (SPINK1, CFTR, other).
  • Data acquisition including markers of inflammatory response during acute attack of chronic pancreatitis.


Original Secondary Outcome:

  • Disruption of activities of normal living.
  • Analgesic use for pancreatic pain.
  • Number of days of hospitalisation for conditions related to pancreatitis.
  • Quality of life (QoL) measures.
  • Markers of inflammatory response and activity of the pancreas.
  • Changes in urinary levels of magnesium, selenium and vitamin C over the duration of the study.
  • Antioxidant response as measured by urinary thiobarituric acid levels.
  • Response in patients with hereditary pancreatitis and idiopathic chronic pancreatitis.
  • Correlate response with gene mutations underlying hereditary pancreatitis (PRSS1, other) and idiopathic chronic pancreatitis (SPINK1, CFTR, other).
  • Data acquisition including makers of inflammatory response during acute attack of chronic pancreatitis.


Information By: University Medicine Greifswald

Dates:
Date Received: August 31, 2005
Date Started: June 2004
Date Completion: December 2008
Last Updated: September 11, 2007
Last Verified: August 2005