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Oral Budesonide vs. Oral Mesalazine in Active Crohn's Disease (CD)

This study has been completed.
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH Identifier:
First received: March 7, 2006
Last updated: May 16, 2014
Last verified: May 2014
The purpose of this study is to determine whether mesalazine or budesonide is more active in the treatment of active Crohn's disease.

Condition Intervention Phase
Crohn's Disease
Drug: budesonide
Drug: mesalazine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Dr. Falk Pharma GmbH:

Primary Outcome Measures:
  • Rate of remission

Secondary Outcome Measures:
  • Response to treatment
  • Time to response
  • Time to remission
  • PGA
  • QoL

Enrollment: 311
Study Start Date: September 2004
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: budesonide
9 mg
Active Comparator: B Drug: mesalazine
4.5 g

Detailed Description:

Crohn's disease is often treated with glucocorticoids or mesalazine. Both drugs are indicated for active Crohn's disease. Treatment with mesalazine is indicated for the treatment of mildly to moderately active Crohn's disease. Budesonide 9 mg/day or mesalazine 4.5 g/day are better than lower doses.

So far only one trial compares the efficacy and safety of budesonide and 5-ASA. The result of this trial is that budesonide is more effective in inducing remission than mesalazine. The primary objective of this trial is to confirm this result for other presentations of budesonide and mesalazine; i.e. Budenofalk® capsules (9 mg/day) and Salofalk® tablets (Eudragit-L-coated oral mesalazine; 4.5 g/day) in moderately active Crohn's disease. Mesalazine is used in this trial as a comparator.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00300118

Ev. Krankenhaus Hattingen GmbH
Hattingen, Germany, 45525
Sponsors and Collaborators
Dr. Falk Pharma GmbH
Principal Investigator: Andreas Tromm, Professor Ev. Krankenhaus Hattingen GmbH
  More Information

Responsible Party: Dr. Falk Pharma GmbH Identifier: NCT00300118     History of Changes
Other Study ID Numbers: BUC-52/CDA
Study First Received: March 7, 2006
Last Updated: May 16, 2014

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Antirheumatic Agents processed this record on March 27, 2017