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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:  NCT01086553
Date of registration: 12/03/2010
Prospective Registration: No
Primary sponsor: Dr. Falk Pharma GmbH
Public title: 9 mg Budesonide Once Daily (OD) Versus 3 mg Budesonide Three Times Daily (TID) in Active Crohn's Disease
Scientific title: Double-blind, Double-dummy, Randomised, Comparative, Multi-centre Phase III Study on the Efficacy and Tolerability of an 8-week Oral Treatment With 9 mg Budesonide Once Daily vs. 3 mg Budesonide Three-times Daily in Patients With Active Crohn's Disease
Date of first enrolment: November 2009
Target sample size: 471
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
Name:     Axel Dignass, Prof.
Affiliation:  Med. Klinik I - Markus-Krankenhaus - Frankfurter Diakonie-Kliniken
Key inclusion & exclusion criteria

Inclusion Criteria:

- Signed informed consent,

- Age 18 to 75 years,

- 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 localisation, pain
intensity, blood in stool) and behaviour (according to Montreal classification)
should be unchanged compared to former episodes],

- Localisation of CD either in terminal ileum, coecum, ascending colon, or ileocolitis,

- Active phase of disease (200 < CDAI < 400),

- Negative pregnancy test in females of childbearing potential,

- Women of child-bearing potential have to apply appropriate contraceptive methods,
e.g., hormonal contraception, intrauterine device (IUD), double-barrier method of
contraception (e.g., use of a condom and spermicide), or partner has undergone
vasectomy. The investigator is responsible for determining whether the subject has
adequate birth control for study participation.

Exclusion Criteria:

- Known Crohn's lesions in the upper GI-tract (up to and including the jejunum) or
rectum with present symptoms,

- Septic complications,

- Evidence of infectious diarrhoea (i.e., pathogenic bacteria in stool culture),

- 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,

- Clinical signs of stricturing disease,

- Subileus within the last 6 months (subileus with inflammatory hint allowed),

- Suspicion of ileus, subileus or corresponding symptoms,

- Parenteral or tube feeding,

- Active peptic ulcer disease, local intestinal infection, or known established

- Diabetes mellitus, infection, osteoporosis, glaucoma, tuberculosis, or hypertension
if careful medical monitoring is not ensured,

- Abnormal hepatic function (ALT or ALP > 2.5 x upper limit of normal [ULN]), liver
cirrhosis, or portal hypertension,

- Abnormal renal function (Cystatin C > ULN),

- Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder,

- History of cancer in the last five years (except for non-metastatic cancers, e.g.,

- Treatment with immunosuppressants or anti-cancer drugs, e.g., 6 TG, methotrexate,
tacrolimus, cyclophosphamide, 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 or other CYP3A inhibitors within the last month before
baseline visit,

- Treatment with anti-TNF-alpha therapy within 3 months before baseline visit,

- Conventional steroids (iv, po, rectal) within 2 weeks before baseline visit,

- > 6 mg/d budesonide po within 2 weeks before baseline visit,

- Steroids for inhalation within 2 weeks before baseline visit,

- Patients known to be steroid-refractory,

- Treatment of study disease with oral antibiotics (e.g., metronidazole or
ciprofloxacin) 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

- Known intolerance/hypersensitivity to study drug,

- Well-founded doubt about the patient's cooperation, e.g., because of addiction to
alcohol or drugs,

- Existing or intended pregnancy or breast-feeding,

- Participation in another clinical trial within the last 30 days, simultaneous
participation in another clinical trial, or previous participation in this trial.

Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Crohn´s Disease
Drug: budesonide
Primary Outcome(s)
Rate of clinical remission, defined as a CDAI < 150, at week 8 (LOCF) [Time Frame: 8 weeks]
Secondary Outcome(s)
Adverse events [Time Frame: 8 weeks]
Response to treatment defined as CDAI < 150 or CDAI reduction of > 100 points [Time Frame: 8 weeks]
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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