Patients with active incomplete microscopic colitis MedDRA version: 19.0 Level: PT Classification code 10056979 Term: Colitis microscopic System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: Budenofalk® 9 mg gastro-resistant granules
Product Name: Budenofalk® 9 mg gastro-resistant granules
Product Code: Budenofalk
Pharmaceutical
Sponsors
Dr. Falk Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent 2. Man or woman between 18 and 80 years of age 3. Histologically established diagnosis of incomplete microscopic colitis 4. History of chronic non-bloody, watery diarrhoea for at least 4 weeks 5. Clinically active disease 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 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 26
Exclusion criteria
Exclusion criteria: 1. Other significant abnormalities in colonoscopy that may have been the cause of diarrhoea except for colonic diverticulosis and non-dysplastic polyps 2.5 x upper limit of normal [ULN]), liver cirrhosis, or portal hypertension, 11. Tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma, cataract, or infection if careful medical monitoring is not ensured, 12. History of colorectal cancer, 13. History of cancer (other than colorectal) in the last 5 years, 14. Therapy with immunomodulators (e.g., azathioprine, 6-mercaptopurine, or methotrexate) within 3 months prior to baseline, 15. Treatment with budesonide or other steroids within 4 weeks prior to baseline, 16. Treatment with antibiotics within 4 weeks prior to baseline, 17. Treatment with anti-diarrhoeal drugs (e.g., loperamide, ispaghula, codeine, and opium), cholestyramine, bulking agents, spasmolytics, bismuth, and probiotics within 2 weeks prior to baseline, 18. Known intolerance/hypersensitivity/resistance to the trial drug or drugs of similar chemical structure or pharmacological profile, 19. Current or intended pregnancy or breast-feeding, 20. Doubt about the patient’s cooperation, e.g. because of addiction to alcohol or drugs, 21. Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial, 22. Live vaccination within the last 4 weeks before the baseline visit, 23. Diagnosis of chickenpox, herpes zoster or measles within the last 3 months before the baseline visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to demonstrate efficacy of budesonide for induction of remission in patients with active incomplete microscopic colitis;Secondary Objective: The second objective of the trial is to study the maintenance of remission after end of treatment and the safety, tolerability of budesonide granules in patients with incomplete microscopic colitis;Primary end point(s): Rate of clinical remission at final/withdrawal visit;Timepoint(s) of evaluation of this end point: After 8 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Double-blind phase: • Rate of clinical remission • Time to remission • Change in total number of stools • Change in number of days with abdominal pain • Change in number of days with bloating • Changes in histological signs • Rate of histological remission/improvement • Physician’s Global Assessment (PGA) • Short Health Scale (SHS) Follow-up phase: • Rate of responders maintaining clinical remission • Rate of patients with relapse • Time to relapse ;Timepoint(s) of evaluation of this end point: Each visit, if not otherwise defined | — |
Countries
Austria, Denmark, Germany, Hungary, Italy, Lithuania, Netherlands, Portugal, Spain, Sweden
Contacts
Public ContactClinical Research and Development
Dr. Falk Pharma GmbH
Outcome results
None listed