Crohn's DiseasePhase 3NCT00300118
Oral Budesonide vs. Oral Mesalazine in Active Crohn's Disease (CD)
A Phase 3 study testing budesonide and mesalazine in people with Crohn's Disease, run by Dr. Falk Pharma GmbH at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether mesalazine or budesonide is more active in the treatment of active Crohn's disease. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- budesonide and mesalazine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 311 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2004to May 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
The purpose of this study is to determine whether mesalazine or budesonide is more active in the treatment of active Crohn's disease.
Read the 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.
- Conditions
- Crohn's Disease
- Being tested
- budesonide, mesalazine
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
budesonideDrug
9 mg
mesalazineDrug
4.5 g
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: budesonide |
| B | Active comparator | Not described Receives: Drug: mesalazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of remission
Secondary outcomes (5)
Response to treatment
Time to response
Time to remission
PGA
QoL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2006 (estimated)
- Study startSep 2004
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Falk Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andreas Tromm, Professor, Principal investigator, Ev. Krankenhaus Hattingen GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300118
- Sponsor's protocol ID
- BUC-52/CDA
- Other IDs
- 2004-001213-34, 2004
- Status last verified
- May 2014
- First submitted
- 7 Mar 2006
- Last updated
- 19 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tromm A, Bunganic I, Tomsova E, Tulassay Z, Lukas M, Kykal J, Batovsky M, Fixa B, Gabalec L, Safadi R, Kramm HJ, Altorjay I, Lohr H, Koutroubakis I, Bar-Meir S, Stimac D, Schaffeler E, 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. 2011 Feb;140(2):425-434.e1; quiz e13-4. doi: 10.1053/j.gastro.2010.11.004. Epub 2010 Nov 9.
PubMed 21070781
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00300118
- Acronym / sponsor ID
- BUC-52/CDA
- Conditions
- Crohn's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- Dr. Falk Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 8 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether mesalazine or budesonide is more active in the treatment of active Crohn's disease.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: budesonide |
| B | Active comparator | Drug: mesalazine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| budesonide9 mg | Drug | A |
| mesalazine4.5 g | Drug | B |
Primary outcome
Rate of remission
5 secondary outcomes
Response to treatment
Time to response
Time to remission
PGA
QoL
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2014.
- Results publication: PubMed 21070781Tromm A, Bunganic I, Tomsova E, Tulassay Z, Lukas M, Kykal J, Batovsky M, Fixa B, Gabalec L, Safadi R, Kramm HJ, Altorjay I, Lohr H, Koutroubakis I, Bar-Meir S, Stimac D, Schaffeler E, 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. 2011 Feb;140(2):425-434.e1; quiz e13-4. doi: 10.1053/j.gastro.2010.11.004. Epub 2010 Nov 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Tromm, Professor principal investigator
Ev. Krankenhaus Hattingen GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing budesonide and mesalazine in people with Crohn's Disease, run by Dr. Falk Pharma GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of remission. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00300118, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2014.