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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 23 December 2013
Main ID:  EUCTR2007-005455-42-NL
Date of registration: 18/09/2008
Prospective Registration: Yes
Primary sponsor: University Medical Center Utrecht
Public title: ENDO ACE TRIAL Endoscopic Balloon Dilatation of stenotic ileocecal anastomosis in Crohn´s disease with or without additive local steroid injection and oral Budenofalk; a randomized controlled trial - ENDO ACE TRIAL
Scientific title: ENDO ACE TRIAL Endoscopic Balloon Dilatation of stenotic ileocecal anastomosis in Crohn´s disease with or without additive local steroid injection and oral Budenofalk; a randomized controlled trial - ENDO ACE TRIAL
Date of first enrolment: 26/02/2009
Target sample size: 42
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-005455-42
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no  
Phase: 
Countries of recruitment
Netherlands
Contacts
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Key inclusion & exclusion 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:
• 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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
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
Intervention(s)

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)

Primary Outcome(s)
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).

Secondary Outcome(s)
Secondary ID(s)
IBD-ENDO-2008-1
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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