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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00142233 |
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Date of registration:
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31/08/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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EUROPAC-2 - Pain Treatment of Hereditary and Idiopathic Pancreatitis
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Scientific title:
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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 |
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Date of first enrolment:
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June 6, 2005 |
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Target sample size:
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295 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00142233 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Germany
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Contacts
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Name:
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Christopher Halloran, Professor,MD,FRCS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Molecular and Clinical Cancer Medicine, University of Liverpool |
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Name:
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Markus M Lerch, Professor,MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Klinik für Innere Medizin A, Universitätsmedizin Greifswald |
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Name:
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Julia V Mayerle, Professor,MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medizinische Klinik II, Klinikum der Universität München |
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Key inclusion & exclusion criteria
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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.
Age minimum:
5 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pancreatitis
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Intervention(s)
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Other: Placebo Magnesiocard (2.5 mmol)
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Drug: Magnesium
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Dietary Supplement: ANTOX (vers.)1.2
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Other: Placebo ANTOX (vers)1.2
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Primary Outcome(s)
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Reduction in the number of days of pancreatic pain.
[Time Frame: 1 year]
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Secondary Outcome(s)
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Antioxidant response as measured by urinary thiobarbituric acid levels.
[Time Frame: 1 year]
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Correlate response with gene mutations underlying hereditary pancreatitis (PRSS1, other) and idiopathic chronic pancreatitis (SPINK1, Cystic Fibrosis Transmembrane Conductance Regulator (CFTR), other).
[Time Frame: 1 year]
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Analgesic use for pancreatic pain.
[Time Frame: 1 year]
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Quality of life (QoL) measures.
[Time Frame: 1 year]
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Response in patients with hereditary pancreatitis and idiopathic chronic pancreatitis.
[Time Frame: 1 year]
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Changes in urinary levels of magnesium, selenium, and vitamin C.
[Time Frame: 1 year]
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Disruption of activities of normal living (patient reports).
[Time Frame: 1 year]
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Markers of inflammatory response and activity of the pancreas.
[Time Frame: 1 year]
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Number of days of hospitalisation for conditions related to pancreatitis.
[Time Frame: 1 year]
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Secondary ID(s)
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EUROPAC-2
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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