Hereditary or idiopathic chronic pancreatitis Digestive System Disorders of gallbladder, biliary tract and pancreas
Conditions
Interventions
Current interventions as of 16/02/2012
Group 1:
Two ANTOX (version 1.2) tablets, three times daily
antioxidant treatment (daily):
1. 300 µg organic selenium
2. 720 mg vitamin C
3. 228 mg vitamin E
4. 2880 mg methionine
antioxidant treatment (daily):
1. 300 µg organic selenium
2. 54000 IU beta-carotene = 18 mg
3. 750 mg vitamin C
4. 540 IU of vitamin E =
Sponsors
The University of Liverpool Clinical Trials Unit (UK)
Eligibility
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 16/02/2012: 1. Patients with pancreatitis diagnosed for at least one year 2. Patients who have provided written informed consent 3. Patients who are willing to be followed up regularly for at least one year 4. Patients who are able and willing to complete Quality of Life and Pain Assessment questionnaires 5. Patients who are able and willing to provide urine and faecal within two weeks of each study visit 6. Patients aged 5 to 65 years of age 7. Individuals with characteristic pancreatic pain that is either intermittent or continuous (two or more episodes during the last 12 months) 8. 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. Current inclusion criteria as of 10/07/2007: 1. Patients with pancreatitis diagnosed for at least one year 2. Patients who are willing to be followed up regularly for at least one year 3. Patients aged 5 to 65 years of age 4. Individuals with characteristic pancreatic pain that is either intermittent or continuous (two 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. Previous 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 4. Individuals must have characteristic pancreatic pain that is either intermittent or continuous (two or more episodes during the last 12 months)
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 16/02/2012: 1. Patients that do not consent to be involved in the trial, or patients under the age of 16 whose parents/guardians do not consent for them to be involved in the trial 2. Patients or parents/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 are currently receiving treatment with antioxidants or magnesium tablets or who have had such treatment within the last 3 months 4. Patients who are currently receiving treatment with oral hypoglycaemics or steroids or who have had such treatment within the last 3 months 5. Patients with renal failure (serum creatinine = 200µmol/l) 6. Patients with atrio-ventricular-block 7. Serum triglyceride levels = 1000mg/dl 8. Patients who are dependent on daily opiate analgesia (morphine or equivalent for more than 12 months) 9. Patients who have chronic hepatic failure, or serious impairment of pulmonary, cardiac, neurological or cerebral function 10. Patients who are participating in another drug trial 11. Patients who are pregnant 12. All men and women of reproductive potential unless using at least two types of contraceptive precautions, one of which must be a condom 13. Lactating mothers 14. Patients with any disorder that would prevent adequate absorption of the active treatment 15. Patients suffering from schizophrenia 16. Patients who smoke more than 20 cigarettes per day 17. Patient has had pancreatic surgery since their last attack of pancreatitis, or is planning to have elective pancreatic surgery within the trial duration Current exclusion criteria as of 10/07/2007: 1. Patients that do not consent to be involved in the trial, or underage patients whose parents/guardians do not consent for them be involved in the trial 2. Patients or parents/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 are currently receiving treatment with antioxidants or magnesium tablets or who have had such treatment within the last three months 4. Patients who are currently receiving treatment with oral hypoglycaemics or steroids or who have had such treatment within the last three months 5. Patients with renal failure (serum creatinine greater than or equal to 200 µg/l) 6. Patients with atrio-ventricular-block 7. Serum triglyceride levels greater than or equal to 1000 mg/dl 8. Patients who are dependent on daily opiate analgesia (morphine or equivalent) for more than 12 months 9. Patients who have chronic hepatic failure, or serious impairment of pulmonary, cardiac, neurological or cerebral function 10. Patients who are participating in another drug trial 11. Patients who are pregnant 12. Women of childbearing age who are not using contraception 13. Lactating mothers 14. Patients with any diso
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in the number of days of pancreatic pain during 12 continuous months of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 16/02/2012: 1. Intensity of pain recorded using a score (0-10) where 0 is no pain and 10 is worst pain imaginable 2. Analgesic consumption assessed using ?morphine equivalents? 3. The number of days spent in hospital due to painful exacerbations of pancreatitis or due to complications arising due to pancreatitis will be obtained from the patient. The clinician responsible for the care of the patient will independently verify this 4. Quality of life (QoL) including activities of daily living Previous secondary outcomes 1. Intensity of pain recorded using a visual analogue score (0 to 10) where 0 is no pain and 10 is the worst pain imaginable; this will be recorded daily in a pain diary by the patient 2. Analgesic consumption assessed using ?pethidine equivalents?; this will be recorded daily in the pain diary by self report (or in case of children by parents? report) 3. The number of days spent in hospital due to painful exacerbations of pancreatitis or due to complications arising due to pancreatitis will be obtained from the patient. The clinician responsible for the care of the patient will independently verify this; hospital stays will be reported as Serious Adverse Events (SAE) and therefore recorded within 24 hours at the leading trial centre 4. Quality of Life (QoL) including activities of daily living, recorded every 12 weeks by self report 5. Inflammatory response and pancreatic activity measured at pre-defined time points and during symptomatic attacks of pancreatitis assessed by the pancreatic inflammation markers, urinary Trypsinogen Activation Peptide (TAP) and urinary amylase and the exocrine sufficiency marker, faecal elastase; this will be recorded every 12 weeks during the study visit 6. Oxidant stress as measured by urinary thiobarbit | — |
Countries
France, Germany, United Kingdom
Outcome results
None listed