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)

Dr. Falk Pharma GmbH0 个研究点目标入组 92 人开始时间: 2009年11月10日最近更新: 2019年11月25日

适应症

试验速览

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•- 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

•- 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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