ISRCTN89489788已完成未知
Randomised controlled trial of 6-Mercaptopurine (6MP) versus placebo to prevent recurrence of Crohn's disease following surgical resection
niversity of Edinburgh, Lothian Health Board, University Hospitals Division (UK)0 个研究点目标入组 234 人开始时间: 2007年6月15日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 234
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
- 性别
- All
入选标准
- •Current inclusion criteria as of 15/03/2011:
- •1. At least 16 years of age in Scotland and 18 years of age in England and Wales
- •2. Established diagnosis of Crohn's disease confirmed at recent resection
- •3. Ileocolonic or small bowel resection within 3 months before screening
- •4. No more than 100 cm of fixed small bowel resected in total. Previous ileocolonic resection is acceptable
- •5. Able to start oral nutrition within the first 2 postoperative weeks
- •6. Normal or heterozygous TPMT (activity present or reduced consistent with carrier status)
- •7. Able to provide written informed consent prior to screening and to comply with the requirements of the study protocol
- •8. Off antibiotics 2 weeks prior to randomisation
- •Previous inclusion criteria:
- •1. Male or female, at least 16 years of age in Scotland and 18 years of age in England and Wales
- •2. Established diagnosis of Crohn?s disease
- •3. Ileocolonic resection within 3 months
- •4. Able to start oral nutrition and medication within the first 2 postoperative weeks
- •5. Normal or heterozygous Thio Purine Methyl-Transferase (TPMT) genotype
- •6. No more than 100 cm of fixed small bowel resected in total. Previous ileocolonic resection is acceptable
- •7. Able to provide written informed consent prior to screening and to comply with the requirements of the study protocol
排除标准
- •Current exclusion criteria as of 15/03/2011:
- •1. Pregnancy at baseline or breastfeeding
- •2. A known hypersensitivity or intolerance to 6MP
- •3. Pancreatitis associated with azathioprine
- •4. Receiving an experimental treatment for Crohn's disease in the 4 weeks prior to study entry
- •5. Known to require further surgery at study entry i.e. for the removal of an abscess developing from the primary surgery
- •6. Strictureplasty procedure alone
- •(Please note that strictureplasty and resection procedure together will not be considered an exclusion)
- •7. Presence of stoma
- •8. Significant haematological, renal or hepatic dysfunction or clinically important lung disease (i.e. liver function tests [except GGT] >x2 upper limit of normal, haemoglobin ¡Ü10, total white blood cell count <3.5, neutrophils <1.5, platelets <100x106/l)
- •9. Systemic infection including hepatitis B, hepatitis C, HIV and active TB
- •10. A diagnosis of indeterminate colitis or ulcerative colitis
- •11. A history of illicit drug or alcohol abuse in the 1 year prior to study entry
- •12. Active or untreated malignancy (excluding basal cell carcinoma and in situ tumours). (Patients who have had successful treatment for malignancy and have been in remission for more than 5 years may be considered for inclusion only after detailed discussion with, and written approval, from the patient's medical oncologist)
- •13. Presence of a medical or psychiatric condition, disease or laboratory abnormality that in the opinion of the PI may place the subject at unacceptable risk during the study
- •14. Homozygous deficient for TPMT (absent activity)
- •15. Evidence of untreated post-operative infection e.g. clostridium difficile, urinary tract infection or chest infection. If these have been appropriately treated in the opinion of the PI, and inclusion criteria 8 is met, this will not be considered an exclusion
- •16. Taking any medication for Crohn's disease
- •Previous exclusion criteria:
- •1. Pregnancy or breastfeeding
- •2. Hypersensitivity or intolerance to 6MP or pancreatitis associated with azathioprine
- •3. Receiving an experimental treatment for Crohn?s disease in the 4 weeks prior to study entry
- •4. Known to require further surgery at study entry
- •5. Presence of stoma
- •6. Significant renal or hepatic dysfunction, clinically important lung disease
- •7. Systemic infection including hepatitis C, HIV and active tuberculosis (TB)
- •8. A diagnosis of indeterminate colitis or ulcerative colitis
- •9. A history of illicit drug or alcohol abuse in the 1 year prior to study entry
- •10. History of cancer - excluding basal cell carcinoma treated more than 5 years previously and in situ tumours
- •11. Presence of a medical or psychiatric condition, disease or laboratory abnormality that in the opinion of the PI may place the subject at unacceptable risk during the study
- •12. Homozygous deficient for TPMT
- •13. Initiation of the following drugs during the study is not allowed: corticosteroids (it is expected that patients may be on corticosteroids at entry. Doses will be tapered according to local protocols), anti-tumour necrosis factor, azathioprine, methotrexate, antibiotics (for a duration of >10 days), non-steroidal anti-inflammatory drugs
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