ENDO ACE TRIAL

INTERVENTION: Trade Name: Budenofalk Product Name: Budenofalk Pharmaceutical Form: Capsule, soft INN or Proposed INN: BUDESONIDE CAS Number: 51333223 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3 ‐mg Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Trade Name: Kenacort Product Name: Kenacort Pharmaceutical Form: Solution for injection INN or Proposed INN: TRIAMCINOLONE CAS Number: 124947 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 40‐mg/ml Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intraileal use (Noncurrent) CONDITION: Crohn's disease. Patients with Crohn's disease with status after ileocecal resection. Stenotic ileocecal anastomosis with symptoms of obstruction. ; MedDRA version: 14.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 ‐ Gastrointestinal disorders PRIMARY OUTCOME: Main Objective: The primary objective of this study is to evaluate the benefit of adding intensive local anti‐inflammatory therapy (Triamcinolone injection therapy combined with 9 mg oral BudenoFalk once daily for 24 weeks) to routine enteric balloon dilatation in Crohn´s disease patients with symptomatic anastomosis Primary end point(s): To evaluate whether the addition of intensive local anti‐inflammatory therapy reduces the recurrence of stenosis and/or need for surgical intervention in routine enteric balloon dilatation in Crohn´s disease patients with symptomatic stenosis of the anastomosis.; ; Secondary Objective: To assess the feasibility and value of radiologic imaging of the anastomosis in the endoscopy suite, and validating Radiological Crohn´s Disease Anastomotic Index (RCDAI). ; ; INCLUSION CRITERIA: Informed consent • Man or woman between 18 and 75 years of age • Established diagnosis of Crohn’s disease Negative stool culture (for exclusion of infectious ileocolitis and Clostridium Difficile infection) • History of ileocecal resection • = 2 symptoms of intestinal obstruction ‐ Intermittent abdominal pain ‐ Abdominal distension ‐ Nausea ‐ Vomiting ‐ Anorexia • Significant stenotic segment (defined as a decrease in calibre of the intestinal lumen with or without a pre‐stenotic dilatation) located at the anastomosis as diagnosed with MR enterography and abdominal ultrasound. 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