EUCTR2008-006957-42-LT进行中（未招募）不适用
Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Signed informed consent,
- •2. Age 18 to 75 years,
- •3. Symptoms of Crohn’s disease since at least 3 months; diagnosis confirmed
- •by endoscopic and histological, or endoscopic and radiological criteria
- •[endoscopy not older than 12 months or if older, then clinical signs (e.g.,pain localisation, pain intensity, blood in stool) and behaviour (according to
- •Montreal classification) should be unchanged compared to former episodes],
- •4. Localisation of CD either in terminal ileum, coecum, ascending colon, or
- •ileocolitis,
- •5. Active phase of disease (200 < CDAI < 400),
- •6. Negative pregnancy test in females of childbearing potential,
- •7. Women of child-bearing potential have to apply appropriate contraceptive
- •methods, e.g., hormonal contraception, intrauterine device (IUD), doublebarrier
- •method of contraception (e.g., use of a condom and spermicide), or
- •partner has undergone vasectomy. The investigator is responsible for
- •determining whether the subject has adequate birth control for study
- •participation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 465
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •1. Known Crohn’s lesions in the upper GI-tract (up to and including the
- •jejunum) or rectum with present symptoms,
- •2. Septic complications,
- •3. Evidence of infectious diarrhoea (i.e., pathogenic bacteria in stool culture),
- •4. Abscess, perforation, or active fistulas,
- •5. Ileostomy or colostomy,
- •6. Resection of more than 50 cm of the ileum,
- •7. Bowel surgery within the last 3 months,
- •8. Immediate surgery required (e.g., major stenosis, serious bleeding,
- •peritonitis, ileus),
- •9. Clinical signs of stricturing disease,
- •10. Subileus within the last 6 months (subileus with inflammatory hint allowed),
- •11. Suspicion of ileus, subileus or corresponding symptoms,
- •12. Parenteral or tube feeding,
- •13. Active peptic ulcer disease, local intestinal infection, or known established
- •14. Diabetes mellitus, infection, osteoporosis, glaucoma, tuberculosis, or
- •hypertension if careful medical monitoring is not ensured,
- •15. Abnormal hepatic function (ALT or ALP > 2.5 x upper limit of normal
- •[ULN]), liver cirrhosis, or portal hypertension,
- •16. Abnormal renal function (Cystatin C > ULN),
- •17. Any severe concomitant cardiovascular, renal, endocrine, or psychiatric
- •18. History of cancer in the last five years (except for non-metastatic cancers,
- •e.g., basalioma),
- •19. Treatment with immunosuppressants or anti-cancer drugs, e.g., 6-TG,
- •methotrexate, tacrolimus, cyclophosphamide, or cyclosporine within the last
- •3 months; in case of treatment with azathioprine or 6-MP the drugs have to
- •be used for maintenance of remission only and dosage has to be unchanged
- •within the last 3 months before baseline visit and during the study,
- •20. Treatment with ketoconazole or other CYP3A inhibitors within the last
- •month before baseline visit,
- •21. Treatment with anti-TNF-a therapy within 3 months before baseline visit,
- •22. Conventional steroids (iv, po, rectal) within 2 weeks before baseline visit,
- •23. > 6 mg/d budesonide po within 2 weeks before baseline visit,
- •24. Steroids for inhalation within 2 weeks before baseline visit,
- •25. Patients known to be steroid-refractory,
- •26. Treatment of study disease with oral antibiotics (e.g., metronidazole or ciprofloxacin) within the last 2 weeks,
- •27. Application of non-steroidal anti-inflammatory drugs (NSAIDs) within
- •2 weeks before baseline visit except = 350 mg/d or short-term acetylsalicylic
- •acid (paracetamol is allowed),
- •28. Known intolerance/hypersensitivity to study drug,
- •29. Well-founded doubt about the patient’s cooperation, e.g., because of
- •addiction to alcohol or drugs,
- •30. Existing or intended pregnancy or breast-feeding,
- •31. Participation in another clinical trial within the last 30 days, simultaneous
- •participation in another clinical trial, or previous participation in this trial.
研究者
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