EUCTR2006-004159-39-DK进行中（未招募）1 期
Double-blind, double-dummy, randomised, place-controlled, mutli-centre phase III clinical study on the efficacy and tolerability on budesonide capsules vs. mesalazine granules vs. placebo for patients with collagenous colitis - Budesonide capsules vs. masalazine vs. placebo in collagenous colitis
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 96
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
- •- > 4 watery/soft stools on at least 4 days in the week prior to baseline
- •(antidiarrheals have to be discontinued 2 weeks before baseline)
- •- > 3 stools per day on average within the last 7 days prior to baseline
- •- Symptoms (chronic watery diarrhea) for at least 3 months before baseline
- •- Complete colonoscopy or (as a minimum requirement) sigmoidoscopy within the last 12 weeks before baseline
- •- Histologically confirmed diagnosis of collagenous colitis
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Evidence of infectious diarrhea (i.e., pathogenic bacteria in stool culture or rectal biopsies)
- •- Treatment with antidiarrheals within the last 2 weeks before baseline
- •- Treatment with budesonide, salicylates, Boswellia serrata extract, steroids, antibiotics, cholestyramine, non-steroidal anti-inflammatory, or other immunosuppressant drugs within the last 4 weeks before baseline. These drugs are allowed for max. 7 days cumulatively between 4 and 12 weeks prior to baseline, in case a colonoscopy is performed during this time period.
- •- Treatment with ketoconazole or other CYP3A inhibitors within the last 4 weeks before baseline
- •- Celiac disease (blood tests and/or oesophagogastroduodenoscopy with histological examination to be performed)
- •- Endoscopic-histologic findings, which may have caused diarrhea (i.e., polyps > 2 cm, tumors, Crohn’s disease, ulcerative colitis, ischemic colitis)
- •- History of partial colonic resection
- •- Diarrhea as a result of the presence of other symptomatic organic disease of the gastrointestinal tract
- •- Active colorectal cancer or a history of colorectal cancer
- •- Active malignancy other than colorectal cancer or treatment with anticancer drugs during the last 5 years. Patients with a history of cancer other than colorectal cancer and at least five years of uneventful follow up and no signs of recurrence may be eligible.
- •- Severe co-morbidity substantially reducing life expectancy
- •- Abnormal hepatic function or liver cirrhosis (ALT, AST or AP >= 2 x ULN)
- •- Abnormal renal function (Cystatin C > ULN)
- •- Active peptic ulcer disease, local intestinal infection
- •- Asthma, diabetes mellitus, infection, osteoporosis, glaucoma, cataract, or cardiovascular disease if careful medical monitoring is not ensured
- •- Hemorrhagic diathesis
研究者
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