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 colitisMedDRA version: 8.1Level: LLTClassification code 10048928Term: Colitis collagenous
- Registration Number
- EUCTR2007-001315-31-HU
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 110
- 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
last month
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective of the trial is to demonstrate the superiority of budesonide compared to placebo as maintenance therapy in keeping patients in remission over a one-year period.;Secondary Objective: - To study safety and tolerability in the form of adverse events and laboratory parameters<br>- To assess patients' health-related quality of life (SHS and PGWB) under maintenance therapy with budesonide;Primary end point(s): Proportion of patients being in remission over 52 weeks, with remission defined as a mean of < 3 stools/day, thereof a mean of < 1 watery stools/day.
- Secondary Outcome Measures
Name Time Method