Status:
COMPLETED
EUROPAC-2 - Pain Treatment of Hereditary and Idiopathic Pancreatitis
Lead Sponsor:
University Medicine Greifswald
Conditions:
Pancreatitis
Eligibility:
All Genders
5-75 years
Phase:
PHASE3
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. ...
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...
Eligibility Criteria
Inclusion
- Patients must have had symptoms of pancreatitis for at least one year.
- Patients must be willing to be followed up regularly for at least one year.
- Patients aged 5 to 75 years of age.
- Individuals must have characteristic pancreatic pain that is either intermittent or continuous (2 or more episodes during the last 12 months)
- 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
- Patients that do not consent to be involved in the trial, or whose parents do not consent for their children to be involved.
- Patients or guardians of underage patients, with learning disabilities or other cognitive or sensory impairments that would prevent adequate understanding of the study requirements.
- Patients who have had recent treatment (\<3 months), or are currently receiving treatment with antioxidants or magnesium tablets.
- Patients who have had recent (\<3 months), or are currently receiving treatment with oral steroids for their pancreatic disease.
- Patients with renal failure (serum creatinine 200 µg/l).
- Patients with atrio-ventricular-block.
- Serum triglyceride levels \>= 1000 mg/dl.
- Patients under the age of five years or over the age of 75 years.
- Patients who are dependent on daily opiate analgesia (morphine or equivalent) for more than 12 months.
- Patients who have chronic hepatic failure, or serious impairment of pulmonary, cardiac, neurological or cerebral function.
- Patients who are participating in another drug trial.
- Patients who are pregnant.
- Women of childbearing age who are not using contraception.
- Lactating mothers.
- Any disorder that would prevent adequate absorption of the active treatment.
Key Trial Info
Start Date :
June 6 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2019
Estimated Enrollment :
295 Patients enrolled
Trial Details
Trial ID
NCT00142233
Start Date
June 6 2005
End Date
September 1 2019
Last Update
March 27 2020
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