Double-blind, double-dummy, randomised, place-controlled, mutli-centre phase III clinical study on the efficacy and tolerability on budesonide capsules vs. mesalazine granules vs. placebo for patients with collagenous colitis - Budesonide capsules vs. masalazine vs. placebo in collagenous colitis

Phase 1

• Conditions: Collagenous colitis; MedDRA version: 9.1Level: LLTClassification code 10048928Term: Colitis collagenous

• Registration Number: EUCTR2006-004159-39-DK
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-27
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

- > 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

Exclusion Criteria

- 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 anti-inflammatory, 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