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

• Register: EUCTR
• Last refreshed on: 15 July 2013
• Main ID: EUCTR2004-001213-34-GB
• Date of registration: 19/08/2008
• 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: 30/01/2007
• 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

Countries of recruitment

Czech Republic, United Kingdom

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 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
· 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
· 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)

Trade Name: Salofalk
Pharmaceutical Form: Tablet
INN or Proposed INN: mesalazine
CAS Number: 89-57-6
Other descriptive name: 5-Aminosalicyl acid
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

Trade Name: Budenofalk
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)

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).

Primary end point(s): Rate of remission, defined as CDAI = 150

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

Secondary ID(s)

2004-001213-34-CZ

BUC-52/CDA