Induction of remission in active Crohn´s disease MedDRA version: 14.1 Level: LLT Classification code 10058815 Term: Crohn's disease acute episode System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Name: Budenofalk 9mg gastro-resistant granules
Product Code: Budenofalk 9mg gastro-resistant granules
Pharmaceutical Form: Gastro-resistant granules
INN or Proposed INN: BUDESONIDE
CAS Number:
Sponsors
Dr. Falk Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent, 2. Age 18 to 75 years, 3. Symptoms of Crohn’s disease since at least 3 months; diagnosis confirmed by endoscopic and histological, or endoscopic and radiological criteria [endoscopy not older than 12 months or if older, then clinical signs (e.g.,pain localisation, pain intensity, blood in stool) and behaviour (according to Montreal classification) should be unchanged compared to former episodes], 4. Localisation of CD either in terminal ileum, coecum, ascending colon, or ileocolitis, 5. Active phase of disease (200 =65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: 1. Known Crohn’s lesions in the upper GI-tract (up to and including the jejunum) or rectum with present symptoms, 2. Septic complications, 3. Evidence of infectious diarrhoea (i.e., pathogenic bacteria in stool culture), 4. Abscess, perforation, or active fistulas, 5. Ileostomy or colostomy, 6. Resection of more than 50 cm of the ileum, 7. Bowel surgery within the last 3 months, 8. Immediate surgery required (e.g., major stenosis, serious bleeding, peritonitis, ileus), 9. Clinical signs of stricturing disease, 10. Subileus within the last 6 months (subileus with inflammatory hint allowed), 11. Suspicion of ileus, subileus or corresponding symptoms, 12. Parenteral or tube feeding, 13. Active peptic ulcer disease, local intestinal infection, or known established cataract, 14. Diabetes mellitus, infection, osteoporosis, glaucoma, tuberculosis, or hypertension if careful medical monitoring is not ensured, 15. Abnormal hepatic function (ALT or ALP > 2.5 x upper limit of normal [ULN]), liver cirrhosis, or portal hypertension, 16. Abnormal renal function (Cystatin C > ULN), 17. Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder, 18. History of cancer in the last five years (except for non-metastatic cancers, e.g., basalioma), 19. Treatment with immunosuppressants or anti-cancer drugs, e.g., 6-TG, methotrexate, tacrolimus, cyclophosphamide, or cyclosporine within the last 3 months; in case of treatment with azathioprine or 6-MP the drugs have to be used for maintenance of remission only and dosage has to be unchanged within the last 3 months before baseline visit and during the study, 20. Treatment with ketoconazole or other CYP3A inhibitors within the last month before baseline visit, 21. Treatment with anti-TNF-a therapy within 3 months before baseline visit, 22. Conventional steroids (iv, po, rectal) within 2 weeks before baseline visit, 23. > 6 mg/d budesonide po within 2 weeks before baseline visit, 24. Steroids for inhalation within 2 weeks before baseline visit, 25. Patients known to be steroid-refractory, 26. Treatment of study disease with oral antibiotics (e.g., metronidazole or ciprofloxacin) within the last 2 weeks, 27. Application of non-steroidal anti-inflammatory drugs (NSAIDs) within 2 weeks before baseline visit except = 350 mg/d or short-term acetylsalicylic acid (paracetamol is allowed), 28. Known intolerance/hypersensitivity to study drug, 29. Well-founded doubt about the patient’s cooperation, e.g., because of addiction to alcohol or drugs, 30. Existing or intended pregnancy or breast-feeding, 31. Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary: • To evaluate the efficacy of 9 mg budesonide once daily (OD) vs. 3 mg budesonide three-times daily (TID) for the induction of remission in Crohn’s disease.;Secondary Objective: Secondary: • To study safety and tolerability of 9 mg budesonide OD vs. 3 mg budesonide TID in the form of adverse events and laboratory parameters, • To evaluate the mucosal healing rate after 8-week treatment with budesonide, • To assess patients’ quality of life.;Primary end point(s): Rate of clinical remission, defined as a CDAI < 150, at week 8 (LOCF) | — |
Countries
Bulgaria, Czech Republic, Germany, Hungary, Latvia, Lithuania, Romania, Russian Federation, Slovakia, Ukraine
Outcome results
None listed