Collagenous colitis MedDRA version: 8.1 Level: LLT Classification code 10048928 Term: Colitis collagenous
Conditions
Interventions
Trade Name: Budenofalk 3 mg
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: BUDESONIDE
CAS Number: 5133-32-23
Concentration unit: mg milligram(s)
Concentration type: equal
Con
Sponsors
Dr. Falk Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion 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 week prior baseline 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
Exclusion criteria: - Other significant abnormalities at colonoscopy that may have been the cause of diarrhoea, with the exception of colonic diverticulosis and polyps 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 - 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. | — |
Countries
Belgium, Czech Republic, Denmark, Germany, Hungary, Sweden
Outcome results
None listed