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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)

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.

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).

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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