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

May 16, 2014 updated by: Dr. Falk Pharma GmbH

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

311

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hattingen, Germany, 45525
        • Ev. Krankenhaus Hattingen GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: B
Drug: mesalazine
4.5 g
Experimental: A
Drug: budesonide
9 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Rate of remission

Secondary Outcome Measures

Outcome Measure
Response to treatment
Time to response
Time to remission
PGA
QoL

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Falk Pharma GmbH

Investigators

  • Principal Investigator: Andreas Tromm, Professor, Ev. Krankenhaus Hattingen GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

March 7, 2006

First Submitted That Met QC Criteria

March 7, 2006

First Posted (Estimate)

March 8, 2006

Study Record Updates

Last Update Posted (Estimate)

May 19, 2014

Last Update Submitted That Met QC Criteria

May 16, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUC-52/CDA
  • 2004-001213-34

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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