EUCTR2007-001315-31-CZ进行中（未招募）不适用
Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study on the efficacy and tolerability of budesonide capsules versus placebo for maintenance of remission in patients with collagenous colitis - SOIBD Collagenous Colitis Maintenance Study (SCCMS)
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
- 110
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
- •- Patients aged >= 18 years,
- •- Histologically established diagnosis of collagenous colitis (CC) defined as:
- •a) Thickened sub-epithelial collagen layer >= 10 µm on well-orientated sections
- •b) Increased amount of inflammatory cells indicating chronic inflammation in the
- •lamina propria
- •- History of non-bloody, watery diarrhoea for more than 2 weeks prior screening in
- •patients with nexly diagnosed collagenous colitis, or history of clinical relapse for
- •more than 1 week prior screening in patients with previously established
- •collagenous colitis
- •- A mean of >= 3 stools/day, thereof a mean of >= 1 watery stolls/day, during the
- •week prior baseline
- •(not applicable for patients having participated in study BUC-60/COC and having
- •been open-labelled treated with 9 mg budesonide OD for 4 weeks under the
- •protocol BUC-60/COC in case of non-response during double-blind treatment or for
- •a relapse during the follow-up period, who are allowed to enter the open-label
- •phase of BUC-63/COC at the -4-week visit and continue with the open-label
- •instruction regimen for period week 5-8.
- •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
- •- Other significant abnormalities at colonoscopy that may have been the cause
- •of diarrhoea, with the exception of colonic diverticulosis and polyps < 2 cm
- •- Infectious cause of diarrhoea
- •- Untreated active celiac disease
- •- Clinical suspicion of drug-induced collagenous colitis
- •- Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder
- •- Abnormal hepatic function (ALT or ALP > 2.5 x upper limit of normal ULN), liver
- •cirrhosis, or portal hypertension
- •- Local intestinal infection
- •- Radiation therapy towards the abdominal or pelvic region
- •- Diabetes mellitus, infection, glaucoma, tuberculosis, peptic uler disease, or hyper-
- •tension if careful medical monitoring is not ensured
- •- Known established cataract
- •- Established osteoporosis with T-score < -2.5
- •- Pregnancy or lactation
- •- History of cancer in the past five years
- •- History of significant bowel resection
- •- Therapy with immunomodulators (azathioprine, 6-mercaptopurine, or
- •methotrexate) in the last 3 months
- •- Treatment with oral, rectal, or intravenous corticosteroids incl. budesonide in the
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