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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.
Last refreshed on: 19 February 2015
Main ID:  NCT00300118
Date of registration: 07/03/2006
Prospective Registration: No
Primary sponsor: Dr. Falk Pharma GmbH
Public title: Oral Budesonide vs. Oral Mesalazine in Active Crohn's Disease (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
Date of first enrolment: September 2004
Target sample size: 311
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
Name:     Andreas Tromm, Professor
Affiliation:  Ev. Krankenhaus Hattingen GmbH
Key inclusion & exclusion criteria

Inclusion Criteria (main):

- 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)

Exclusion Criteria (main):

- Known Crohn's lesion 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

- 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

- Clinical signs of stricturing disease

- Subileus within the last 6 months

- Suspicion of ileus, subileus or corresponding symptomatology

- Contra-indications, special warnings and precautions mentioned in SmPC

- Treatment with immunosuppressants, cytostatics, 6-TG, methotrexate, or cyclosporine
within the last 3 months; in case of treatment with azathioprine 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-a 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

Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Crohn's Disease
Drug: budesonide
Drug: mesalazine
Primary Outcome(s)
Rate of remission
Secondary Outcome(s)
Response to treatment
Time to remission
Time to response
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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