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)

• Conditions: Collagenous colitis; MedDRA version: 8.1Level: LLTClassification code 10048928Term: Colitis collagenous

• Registration Number: EUCTR2007-001315-31-SE
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-12
• Last Update Posted: 23 February 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

- 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
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

Exclusion Criteria

- 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
last month

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified