EUCTR2007-001315-31-BE
Active, not recruiting
Phase 1
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)
ConditionsCollagenous colitisMedDRA version: 8.1 Level: LLT Classification code 10048928 Term: Colitis collagenous
DrugsBudenofalk 3 mg
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Collagenous colitis
- Sponsor
- Dr. Falk Pharma GmbH
- Enrollment
- 92
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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