Collagenous colitis MedDRA version: 14.0 Level: PT Classification code 10048928 Term: Colitis collagenous System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: Budenofalk 3 mg
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: BUDESONIDE
CAS Number: 5133-32-23
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number
Sponsors
Dr. Falk Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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 colonscopy 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: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 22
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 - 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;Timepoint(s) of evaluation of this end point: 8 weeks treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Rate of clinical remission (? 3 stools per day) after 2 weeks, • Time to remission, • Impact on stool consistency (watery/soft/solid), • Impact on abdominal pain, • Impact on patient’s general well-being, • Effect on histopathology (i.e., collagen band thickness, inflammation of the lamina propria, restoration of degenerated surface epithelium), • Severity of diarrhea • Number of days with diarrhea (> 3 stools per day), • Number of days with stools of solid consistency, • Number of days with stools of soft or solid consistency, • Number of days with stools of soft consistency, • Number of days with stools of watery consistency, • Average frequency of stools per week, • Quality of life by GIQLI, • Physician’s Global Assessment (PGA) • Number of patients maintaining clinical remission during follow-up phase, • Number of placebo non-responders experiencing clinical remission during open-label phase • Number of patients with clinical relapse experiencing clinical remission ;Timepoint(s) of evaluation of this end point: whole study | — |
Countries
Germany, Lithuania, Spain, United Kingdom
Contacts
Public ContactSponsor
Dr. Falk Pharma GmbH
Outcome results
None listed