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
Conditions
Interventions
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
Co
Sponsors
University Medical Center Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: • A stenotic segment of more than 5 cm • Rutgeerts score i4 inflammation at the site of stenosis • Fistulas at the site of stenosis or in the near proximity • A stenosis that cannot be properly endoscopically visualized • A significant stenosis proximal to the stenotic anastomosis • The concomitant use of other oral drugs containing budesonide within 4 weeks of screening • Pregnancy, lactation, or intended pregnancy within 9 months • Serious secondary illnesses of an acute or chronic nature (e.g., acute cardiovascular disease, active infection) • Known intolerance/hypersensitivity to the study drug • Well-founded doubt about the patient’s cooperation and/or compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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;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). ;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. | — |
Countries
Netherlands
Outcome results
None listed