Double-blind, double-dummy, randomised, placebo-controlled, multi-centre phase III clinical study on the efficacy and tolerability of budesonide capsules vs. mesalazine granules vs. placebo for patients with collagenous colitisProtocol version 2.0/26.02.2007 incl. amendment 01, and country-specific amendment 02 version 1.0/05.06.2007 - Budesonide capsules vs. mesalazine vs. placebo in collagenous colitis
- Conditions
- Collagenous colitisMedDRA version: 8.1Level: LLTClassification code 10048928Term: Colitis collagenous
- Registration Number
- EUCTR2006-004159-39-GB
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 96
- > 4 watery/soft stools on at least 4 days in the week prior to baseline (antidiarrheals have to be discontinued 2 weeks before baseline)
- > 3 stools per day on average within the last 7 days prior to baseline
- Symptoms (chronic watery diarrhea) for at least 3 months before baseline
- Complete colonoscopy or (as a minimum requirement) sigmoidoscopy within the last 12 weeks before baseline
- Histologically confirmed diagnosis of collagenous colitis
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
- Evidence of infectious diarrhea (i.e., pathogenic bacteria in stool culture or rectal biopsies)
- Treatment with antidiarrheals within the last 2 weeks before baseline
- Treatment with budesonide, salicylates, Boswellia serrata extract, steroids, antibiotics, cholestyramine, non-steroidal and antiflammatory, or other immunosuppressant drugs within the last 4 weeks before baseline. These drugs are allowed for max. 7 days cumulatively between 4 and 12 weeks prior to baseline, in case, a colonoscopy is performed during this time period.
- Treatment with ketoconazole or other CYP3A inhibitors within the last 4 weeks before baseline
- Celiac disease (blood tests and/or oesophagogastroduodenoscopy with histological examination to be performed)
- Endoscopic-histologic findings, which may have caused diarrhea (i.e., polyps > 2 cm, tumors, Crohn's disease, ulcerative colitis, ischemic colitis
- History of partial colonic resection
- Diarrhea as a result of the presence of other symptomatic organic disease of the gastrointestinal tract
- Active colorectal cancer or a history of colorectal cancer
- Active malignancy other than colorectal cancer or treatment with anticancer drugs during the last 5 years. Patients with a history of cancer other than colorectal cancer and at least five years of uneventful follow up and no signs of recurrence may be eligible.
- Severe co-morbidity substantially reducing life expectancy
- Abnormal hepatic function or liver cirrhosis (ALT, AST or AP >= 2 x ULN)
- Abnormal renal function (Cystatin C > ULN)
- Active peptic ulcer disease, local intestinal infection
- Asthma, diabetes mellitus, infection, osteoporosis, glaucoma, cataract, or cardiovascular disease if careful medical monitoring is not ensured
- Hemorrhagic diathesis
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 compare the efficacy of budesonide (9 mg budesonide/d) vs. mesalazine granules (3 g 5-ASA/d) vs. placebo for the treatment of collagenous colitis.;Secondary Objective: - To study safety and tolerability in the form of adverse events and laboratory parameters<br>- To assess patients' quality of life;Primary end point(s): Rate of clinical remission ( <= 3 stools per day in the last 7 days) after 8 weeks
- Secondary Outcome Measures
Name Time Method