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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00300118
Recruitment Status : Completed
First Posted : March 8, 2006
Last Update Posted : May 19, 2014
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH

Brief Summary:
The purpose of this study is to determine whether mesalazine or budesonide is more active in the treatment of active Crohn's disease.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: budesonide Drug: mesalazine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 311 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2004
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Budesonide

Arm Intervention/treatment
Experimental: A Drug: budesonide
9 mg

Active Comparator: B Drug: mesalazine
4.5 g

Primary Outcome Measures :
  1. Rate of remission

Secondary Outcome Measures :
  1. Response to treatment
  2. Time to response
  3. Time to remission
  4. PGA
  5. QoL

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00300118

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Ev. Krankenhaus Hattingen GmbH
Hattingen, Germany, 45525
Sponsors and Collaborators
Dr. Falk Pharma GmbH
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Principal Investigator: Andreas Tromm, Professor Ev. Krankenhaus Hattingen GmbH
Publications of Results:
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Responsible Party: Dr. Falk Pharma GmbH Identifier: NCT00300118    
Other Study ID Numbers: BUC-52/CDA
First Posted: March 8, 2006    Key Record Dates
Last Update Posted: May 19, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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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