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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:
NCT00300118
First received: March 7, 2006
Last updated: May 16, 2014
Last verified: May 2014
  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 3

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Responsible Party: Dr. Falk Pharma GmbH
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: May 16, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Crohn Disease
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Budesonide
Mesalamine
Analgesics
Analgesics, Non-Narcotic
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Autonomic Agents
Bronchodilator Agents
Central Nervous System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014