Oral Budesonide vs. Oral Mesalazine in Active Crohn's Disease (CD) - Full Text View

Sponsor:	Dr. Falk Pharma GmbH
Information provided by:	Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:	NCT00300118

Purpose

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 III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study 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:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Budesonide Mesalamine

U.S. FDA Resources

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300118

Locations

Germany
Ev. Krankenhaus Hattingen GmbH
Hattingen, Germany, 45525

Sponsors and Collaborators

Dr. Falk Pharma GmbH

Investigators

Principal Investigator:

Andreas Tromm, Professor

Ev. Krankenhaus Hattingen GmbH

More Information

Publications:

Tromm A, Bunganic I, Tomsová E, Tulassay Z, Luká M, Kykal J, Bátovský M, Fixa B, Gabalec L, Safadi R, Kramm HJ, Altorjay I, Löhr H, Koutroubakis I, Bar-Meir S, Timac D, Glasmacher C, Dilger K, Mohrbacher R, Greinwald R; International Budenofalk® Study Group. Budesonide (9 mg) is at Least as Effective as Mesalamine (4.5 g) in Patients with Mildly to Moderately Active Crohn's disease. Gastroenterology. 2010 Nov 8; [Epub ahead of print]

ClinicalTrials.gov Identifier:	NCT00300118 History of Changes
Other Study ID Numbers:	BUC-52/CDA, 2004-001213-34
Study First Received:	March 7, 2006
Last Updated:	February 2, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Budesonide
Mesalamine
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012