Crohn´s DiseasePhase 3NCT01086553
9 mg Budesonide Once Daily (OD) Versus 3 mg Budesonide Three Times Daily (TID) in Active Crohn's Disease
A Phase 3 study testing budesonide in people with Crohn´s Disease, run by Dr. Falk Pharma GmbH at 1 site in Germany.
Trial summary
This study aims to evaluate the efficacy of 9 mg budesonide once daily (OD) versus 3 mg budesonide three-times daily (TID) for the induction of remission in Crohn's disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn´s Disease
- What is being tested?
- budesonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 471 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2009to Dec 2012
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent,
- Age 18 to 75 years,
- 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 localisation, pain intensity, blood in stool) and behaviour (according to Montreal classification) should be unchanged compared to former episodes],
- Localisation of CD either in terminal ileum, coecum, ascending colon, or ileocolitis,
- Active phase of disease (200 < CDAI < 400),
- Negative pregnancy test in females of childbearing potential,
- Women of child-bearing potential have to apply appropriate contraceptive methods, e.g., hormonal contraception, intrauterine device (IUD), double-barrier method of contraception (e.g., use of a condom and spermicide), or partner has undergone vasectomy. The investigator is responsible for determining whether the subject has adequate birth control for study participation.
Who cannot join
- Known Crohn's lesions in the upper GI-tract (up to and including the jejunum) or rectum with present symptoms,
- Septic complications,
- Evidence of infectious diarrhoea (i.e., pathogenic bacteria in stool culture),
- Abscess, perforation, or active fistulas,
- Ileostomy or colostomy,
- Resection of more than 50 cm of the ileum,
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- Bowel surgery within the last 3 months,
- Immediate surgery required (e.g., major stenosis, serious bleeding, peritonitis, ileus),
- Clinical signs of stricturing disease,
- Subileus within the last 6 months (subileus with inflammatory hint allowed),
- Suspicion of ileus, subileus or corresponding symptoms,
- Parenteral or tube feeding,
- Active peptic ulcer disease, local intestinal infection, or known established cataract,
- Diabetes mellitus, infection, osteoporosis, glaucoma, tuberculosis, or hypertension if careful medical monitoring is not ensured,
- Abnormal hepatic function (ALT or ALP > 2.5 x upper limit of normal [ULN]), liver cirrhosis, or portal hypertension,
- Abnormal renal function (Cystatin C > ULN),
- Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder,
- History of cancer in the last five years (except for non-metastatic cancers, e.g., basalioma),
- Treatment with immunosuppressants or anti-cancer drugs, e.g., 6 TG, methotrexate, tacrolimus, cyclophosphamide, 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 or other CYP3A inhibitors within the last month before baseline visit,
- Treatment with anti-TNF-alpha therapy within 3 months before baseline visit,
- Conventional steroids (iv, po, rectal) within 2 weeks before baseline visit,
- > 6 mg/d budesonide po within 2 weeks before baseline visit,
- Steroids for inhalation within 2 weeks before baseline visit,
- Patients known to be steroid-refractory,
- Treatment of study disease with oral antibiotics (e.g., metronidazole or ciprofloxacin) within the last 2 weeks,
- Application of non-steroidal anti-inflammatory drugs (NSAIDs) within 2 weeks before baseline visit except ≤ 350 mg/d or short-term acetylsalicylic acid (paracetamol is allowed),
- Known intolerance/hypersensitivity to study drug,
- Well-founded doubt about the patient's cooperation, e.g., because of addiction to alcohol or drugs,
- Existing or intended pregnancy or breast-feeding,
- Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Med. Klinik I - Markus-Krankenhaus - Frankfurter Diakonie-Kliniken
Frankfurt, 60431
About this study
Official title: Double-blind, Double-dummy, Randomised, Comparative, Multi-centre Phase III Study on the Efficacy and Tolerability of an 8-week Oral Treatment With 9 mg Budesonide Once Daily vs. 3 mg Budesonide Three-times Daily in Patients With Active Crohn's Disease
This study aims to evaluate the efficacy of 9 mg budesonide once daily (OD) versus 3 mg budesonide three-times daily (TID) for the induction of remission in Crohn's disease.
- Conditions
- Crohn´s Disease
- Being tested
- budesonide
- Keywords
- Crohn´s disease, budesonide, induction of remission
- 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
9mg budesonide OD
budesonideDrug
3mg budesonide TID
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 9mg budesonide OD Receives: Drug: budesonide |
| B | Active comparator | 3mg budesonide TID Receives: Drug: budesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clinical remission, defined as a CDAI < 150, at week 8 (LOCF)
Measured: 8 weeks
Secondary outcomes (2)
Response to treatment defined as CDAI < 150 or CDAI reduction of > 100 points
Measured: 8 weeks
Adverse events
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2010 (estimated)
- Study startNov 2009
- Primary completionMay 2012
- Study completionDec 2012
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
- 471 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Falk Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Axel Dignass, Prof., Principal investigator, Med. Klinik I - Markus-Krankenhaus - Frankfurter Diakonie-Kliniken
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01086553
- Sponsor's protocol ID
- BUG-2/CDA
- Other IDs
- 2008-006957-42, 2008
- Status last verified
- Oct 2014
- First submitted
- 12 Mar 2010
- Last updated
- 30 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dignass A, Stoynov S, Dorofeyev AE, Grigorieva GA, Tomsova E, Altorjay I, Tuculanu D, Bunganic I, Pokrotnieks J, Kupcinskas L, Dilger K, Greinwald R, Mueller R; International Budenofalk Study Group. Once versus three times daily dosing of oral budesonide for active Crohn's disease: a double-blind, double-dummy, randomised trial. J Crohns Colitis. 2014 Sep;8(9):970-80. doi: 10.1016/j.crohns.2014.01.021. Epub 2014 Feb 15.
PubMed 24534142
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Double-dummy, Randomised, Comparative, Multi-centre Phase III Study on the Efficacy and Tolerability of an 8-week Oral Treatment With 9 mg Budesonide Once Daily vs. 3 mg Budesonide Three-times Daily in Patients With Active Crohn's Disease
- ClinicalTrials.gov ID
- NCT01086553
- Acronym / sponsor ID
- BUG-2/CDA
- Conditions
- Crohn´s Disease
- Keywords
- Crohn´s disease, budesonide, induction of remission
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 471 participants (actual)
- Lead sponsor
- Dr. Falk Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 15 Mar 2010 (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.
This study aims to evaluate the efficacy of 9 mg budesonide once daily (OD) versus 3 mg budesonide three-times daily (TID) for the induction of remission in Crohn's disease.
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: budesonide9mg budesonide OD |
| B | Active comparator | Drug: budesonide3mg budesonide TID |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent,
- Age 18 to 75 years,
- 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 localisation, pain intensity, blood in stool) and behaviour (according to Montreal classification) should be unchanged compared to former episodes],
- Localisation of CD either in terminal ileum, coecum, ascending colon, or ileocolitis,
- Active phase of disease (200 < CDAI < 400),
Key exclusion criteria (31 listed)
- Known Crohn's lesions in the upper GI-tract (up to and including the jejunum) or rectum with present symptoms,
- Septic complications,
- Evidence of infectious diarrhoea (i.e., pathogenic bacteria in stool culture),
- Abscess, perforation, or active fistulas,
- Ileostomy or colostomy,
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 |
|---|---|---|
| budesonide9mg budesonide OD | Drug | A |
| budesonide3mg budesonide TID | Drug | B |
Primary outcome
Rate of clinical remission, defined as a CDAI < 150, at week 8 (LOCF)
Time frame: 8 weeks
2 secondary outcomes
Response to treatment defined as CDAI < 150 or CDAI reduction of > 100 points
Time frame: 8 weeks
Adverse events
Time frame: 8 weeks
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 30 Oct 2014.
- Results publication: PubMed 24534142Dignass A, Stoynov S, Dorofeyev AE, Grigorieva GA, Tomsova E, Altorjay I, Tuculanu D, Bunganic I, Pokrotnieks J, Kupcinskas L, Dilger K, Greinwald R, Mueller R; International Budenofalk Study Group. Once versus three times daily dosing of oral budesonide for active Crohn's disease: a double-blind, double-dummy, randomised trial. J Crohns Colitis. 2014 Sep;8(9):970-80. doi: 10.1016/j.crohns.2014.01.021. Epub 2014 Feb 15.
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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.
Axel Dignass, Prof. principal investigator
Med. Klinik I - Markus-Krankenhaus - Frankfurter Diakonie-Kliniken
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 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 7 inclusion and 31 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 30 Oct 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 clinical remission, defined as a CDAI < 150, at week 8 (LOCF) (time frame: 8 weeks). 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 NCT01086553, 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 30 Oct 2014.