EUROPAC-2 - Pain Treatment of Hereditary and Idiopathic Pancreatitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by University Medicine Greifswald.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Medicine Greifswald
ClinicalTrials.gov Identifier:
NCT00142233
First received: August 31, 2005
Last updated: September 11, 2007
Last verified: August 2005
  Purpose

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.


Condition Intervention Phase
Pancreatitis
Drug: Magnesium (15 mmol/d)
Drug: ANTOX (vers.) 1.2 (300 µg organic selenium, 54000 IU beta carotene, 750 mg vitamin C, 540 IU vitamin E, 2700 mg methionine)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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 Idiopathic Chronic Pancreatitis

Resource links provided by NLM:


Further study details as provided by University Medicine Greifswald:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 240
Study Start Date: June 2004
Estimated Study Completion Date: December 2008
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 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)

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

  Eligibility

Ages Eligible for Study:   5 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have had pancreatitis diagnosed 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 40 years of age.
  4. Individuals must have characteristic pancreatic pain that is either intermittent or continuous.

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 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 hypoglycaemics or steroid treatment.
  5. Patients with renal failure (serum creatinine  200 g/l).
  6. Patients with atrio-ventricular-block.
  7. Serum triglyceride levels  1000 mg/dl.
  8. Patients under the age of 5 years or over the age of 40 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00142233

Contacts
Contact: Markus M Lerch, Professor of Medicine 03834-86 ext 7230 lerch@uni-greifswald.de
Contact: Julia V Mayerle, MD 03834-86 ext 7244 mayerle@uni-greifswald.de

Locations
Germany
Department of Visceral and Transplant Surgery, Ruprecht-Karls-Universität Heidelberg Recruiting
Heidelberg, Baden-Würtemberg, Germany
Contact: Jeannine Bachmann, MD    +49/6221/56 ext 36459    jeannine_bachmann@med.uni-heidelberg.de   
Contact: Helmut Friess, Professor of Surgery    ++49/6221/56 ext 6902    helmut_friess@uni-heidelberg.de   
Principal Investigator: Helmut Friess, Professor of Surgery         
Sub-Investigator: Jeannine Bachmann, MD         
Sponsors and Collaborators
University Medicine Greifswald
Investigators
Principal Investigator: Markus M Lerch, Professor of Medicine Department of Gastroenterology, Endocrinology and Nutrition, Ernst-Moritz-Arndt University Greifswald
Principal Investigator: Julia V Mayerle, MD Department of Gastroenterology, Endocrinology and Nutrition, Ernst-Moritz-Arndt University Greifswald
Principal Investigator: John P Neoptolemos, Professor of Surgery Department of Surgery, University of Liverpool
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00142233     History of Changes
Other Study ID Numbers: EUROPAC-2
Study First Received: August 31, 2005
Last Updated: September 11, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Medicine Greifswald:
EUROPAC 2, ANTOX (vers)1.2, MGCT (Magnesiocard) Hereditary Pancreatitis, Idiopathic chronic pancreatitis.
Hereditary Pancreatitis
idiopathic chronic pancreatitis

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases
Ascorbic Acid
Vitamin E
Vitamins
Beta Carotene
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 23, 2014