ISRCTN44912429进行中（未招募）未知
Double blind randomised controlled trial to investigate the efficacy of ANTOX (version 1.2) and MGCT (Magnesium) for the treatment of hereditary and idiopathic chronic pancreatitis
The University of Liverpool Clinical Trials Unit (UK)0 个研究点目标入组 295 人开始时间: 2007年5月30日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 295
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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)
排除标准
- •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
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