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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: 7 August 2012
Main ID:  EUCTR2008-006957-42-CZ
Date of registration: 07/09/2009
Prospective Registration: Yes
Primary sponsor: Dr. Falk Pharma GmbH
Public 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 - 9 mg budesonide OD vs. 3 mg budesonide 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 - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease
Date of first enrolment: 24/09/2009
Target sample size: 400
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-006957-42
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: yes Other trial design description: Double-dummy If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no  
Phase: 
Countries of recruitment
Bulgaria Czech Republic Germany Hungary Latvia Lithuania Slovakia
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
1. Signed informed consent,
2. Age 18 to 75 years,
3. 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],
4. Localisation of CD either in terminal ileum, coecum, ascending colon, or
ileocolitis,
5. Active phase of disease (200 < CDAI < 400),
6. Negative pregnancy test in females of childbearing potential,
7. Women of child-bearing potential have to apply appropriate contraceptive
methods, e.g., hormonal contraception, intrauterine device (IUD), doublebarrier
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.
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:
1. Known Crohn’s lesions in the upper GI-tract (up to and including the
jejunum) or rectum with present symptoms,
2. Septic complications,
3. Evidence of infectious diarrhoea (i.e., pathogenic bacteria in stool culture),
4. Abscess, perforation, or active fistulas,
5. Ileostomy or colostomy,
6. Resection of more than 50 cm of the ileum,
7. Bowel surgery within the last 3 months,
8. Immediate surgery required (e.g., major stenosis, serious bleeding,
peritonitis, ileus),
9. Clinical signs of stricturing disease,
10. Subileus within the last 6 months (subileus with inflammatory hint allowed),
11. Suspicion of ileus, subileus or corresponding symptoms,
12. Parenteral or tube feeding,
13. Active peptic ulcer disease, local intestinal infection, or known established
cataract,
14. Diabetes mellitus, infection, osteoporosis, glaucoma, tuberculosis, or
hypertension if careful medical monitoring is not ensured,
15. Abnormal hepatic function (ALT or ALP > 2.5 x upper limit of normal
[ULN]), liver cirrhosis, or portal hypertension,
16. Abnormal renal function (Cystatin C > ULN),
17. Any severe concomitant cardiovascular, renal, endocrine, or psychiatric
disorder,
18. History of cancer in the last five years (except for non-metastatic cancers,
e.g., basalioma),
19. 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,
20. Treatment with ketoconazole or other CYP3A inhibitors within the last
month before baseline visit,
21. Treatment with anti-TNF-a therapy within 3 months before baseline visit,
22. Conventional steroids (iv, po, rectal) within 2 weeks before baseline visit,
23. > 6 mg/d budesonide po within 2 weeks before baseline visit,
24. Steroids for inhalation within 2 weeks before baseline visit,
25. Patients known to be steroid-refractory,
26. Treatment of study disease with oral antibiotics (e.g., metronidazole or ciprofloxacin) within the last 2 weeks,
27. 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),
28. Known intolerance/hypersensitivity to study drug,
29. Well-founded doubt about the patient’s cooperation, e.g., because of
addiction to alcohol or drugs,
30. Existing or intended pregnancy or breast-feeding,
31. 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
Induction of remission in active Crohn´s disease
MedDRA version: 12.0 Level: LLT Classification code 10058815 Term: Crohn's disease acute episode
MedDRA version: 12.0 Level: PT Classification code 10011401 Term: Crohn's disease
Intervention(s)

Product Name: Budenofalk 9mg gastro-resistant granules
Product Code: Budenofalk 9mg gastro-resistant granules
Pharmaceutical Form: Gastro-resistant granules
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 9-
Pharmaceutical form of the placebo: Gastro-resistant granules
Route of administration of the placebo: Oral use

Trade Name: Budenofalk 3mg gastro-resistant capsules
Product Name: Budenofalk 3mg gastro-resistant capsules
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 9-
Pharmaceutical form of the placebo: Gastro-resistant capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)
Main Objective: Primary:
• To evaluate the efficacy of 9 mg budesonide once daily (OD) vs. 3 mg
budesonide three-times daily (TID) for the induction of remission in Crohn’s
disease.
Primary end point(s): Rate of clinical remission, defined as a CDAI < 150, at week 8 (LOCF)
Secondary Objective: Secondary:
• To study safety and tolerability of 9 mg budesonide OD vs. 3 mg budesonide
TID in the form of adverse events and laboratory parameters,
• To evaluate the mucosal healing rate after 8-week treatment with budesonide,
• To assess patients’ quality of life.
Secondary Outcome(s)
Secondary ID(s)
2008-006957-42-DE
BUG-2/CDA
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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