World Health Organization site
Skip Navigation Links

Main
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: 31 January 2017
Main ID:  EUCTR2004-001213-34-SK
Date of registration: 16/08/2005
Prospective Registration: No
Primary sponsor: Dr. Falk Pharma GmbH
Public title: Double-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CD
Scientific title: Double-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CD
Date of first enrolment: 16/12/2004
Target sample size: 370
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001213-34
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: yes Other trial design description: double-dummy If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: yes Other specify the comparator: different dosage scheme  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Czech Republic Slovakia United Kingdom
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria:
· Signed informed consent
· Man or woman between 18 and 70 years of age
· 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 localization, pain intensity, blood in stool) and behaviour (according to Vienna classification) should be unchanged compared to former episodes]
· Localisation of CD either in terminal ileum, ascending colon or ileocolitis
· Active phase of disease (200 < CDAI < 400)
· Negative pregnancy test at baseline visit week 0 in females of childbearing potential
· Use of appropriate contraceptive methods for females of childbearing potential during treatment (e.g. hormonal contraception, intrauterine device [IUD])
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:
· Known Crohn’s lesions in the upper GI-tract (up to and including the jejunum) with present symptoms
· CD in the rectum currently present
· Short bowel syndrome
· Septic complications
· Baseline stool positive for germs causing bowel disease
· Hemorrhagic diathesis
· Abscess, perforation or active fistulas
· Ileostomy or colostomy
· Resection of more than 50 cm of the ileum
· Bowel surgery within the last 3 months
· Immediate surgery required (e.g. major stenosis, serious bleeding, peritonitis, ileus)
· Clinical signs of stricturing disease
· Subileus within the last 6 months (subileus with inflammatory hint allowed)
· Suspicion of ileus, subileus or corresponding symptomatology
· Parenteral or tube feeding
· Active peptic ulcer disease, local intestinal infection, or if careful medical monitoring is not ensured: asthma, diabetes mellitus, infection or cardiovascular disease.
· Abnormal hepatic function or liver cirrhosis (ALT, AST or AP > 2 x ULN)
· Abnormal renal function (e.g. serum Creatinine > 1,5 mg/dl)
· Active malignancy or treatment with anticancer drugs during the last 5 years. Patients with a history of cancer and at least five years of uneventful follow up and no signs of recurrence may be eligible.
· Treatment with immuno-suppressants, cytostatics, 6-TG, methotrexate, or cyclosporine within the last 3 months; in case of treatment with azothioprine 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.
· Treatment with ketoconazole, ciprofloxacin or other CYP3A inhibitors within the last month before baseline visit
· Treatment with anti-TNF-alpha therapy within 6 months before baseline visit
· Conventional steroids (iv, po, rectal) within 2 weeks before the study
· > 6 mg/d budesonide po or > 3 g/d mesalazine po within 2 weeks before the study
· Patients known to be steroid-refractory or steroid-dependent from former CD episodes
· Treatment of study disease with oral antibiotics (e.g., metronidazole) within the last 2 weeks
· 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)
· Known intolerance/hypersensitivity to study drugs or drugs of similar chemical structure or pharmacological profile
· Well-founded doubt about the patient’s cooperation, e.g. because of addiction to alcohol or drugs
· Existing or intended pregnancy or lactation
· Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
moderately active Crohn’s disease (200 < CDAI < 400)
MedDRA version: 7.0 Level: PT Classification code 10011401
Intervention(s)

Pharmaceutical Form: Tablet
INN or Proposed INN: mesalazine
CAS Number: 89-57-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Pharmaceutical Form: Capsule, hard
INN or Proposed INN: budesonide
CAS Number: 51333-22-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)
Main Objective: to assess the efficacy of oral budesonide (9 mg/day) vs. oral mesalazine (4.5 g/day) in moderately active Crohn’s disease
Primary end point(s): Rate of remission, defined as CDAI = 150
Secondary Objective: to assess the efficacy of two dose regimens (9 mg od vs. 3 mg tid) of budesonide and to examine the safety (e.g., adverse events, lab parameters).
Secondary Outcome(s)
Secondary ID(s)
2004-001213-34-CZ
BUC-52/CDA
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history