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Budenofalk granules and capsules in the treatment of Crohn's disease


- candidate number24737
- NTR NumberNTR5997
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-aug-2016
- Secondary IDsBUG-004CDA Dr. Falk Pharma Benelux B.V.
- Public TitleBudenofalk granules and capsules in the treatment of Crohn's disease
- Scientific TitleBudenofalk granules and capsules in the treatment of active Crohn's disease - a prospective, multicenter, observational study
- ACRONYMBALANCE
- hypothesisThe purpose of this observational study is to obtain insight into the treatment of the acute phase of Crohn’s disease with Budenofalk® 9 mg granules and 3 mg capsules among outpatients attending regular gastroenterological practice. Likely, different dosing schedules and treatment durations are employed for the induction of remission. We aim to discover how these differences affect therapeutic adherence, success of therapy, patient experience, and drug tolerability.
- Healt Condition(s) or Problem(s) studiedCrohn's disease, IBD, Budesonide
- Inclusion criteriaage > 18 years;

seen in the outpatient department; have been prescribed Budenofalk granules or capsules for the treatment of mild to moderate active Crohn's disease;
have received adequate information regarding this observational study and have voluntarily agreed to the use of their data
- Exclusion criteriahave severe active Crohn's disease;
are being treated with corticosteroids for current flare;
are hypersensitive to the active substance or any of the excipients;
are enrolled and involved in an interventional study
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-nov-2016
- planned closingdate31-okt-2017
- Target number of participants138
- InterventionsNone. This is a prospective, multicenter, observational study. This means that intervention is not the purpose of this study; patients will be treated solely as part of regular medical therapy. Therapeutic necessity will be the only determinant of selection of the medicine.
- Primary outcomeThe objective of this study is to obtain an insight into the treatment of acute Crohn’s disease with Budenofalk 9 mg granules and 3 mg capsules among outpatients attending regular gastroenterological practice. The primary outcome is the percentage of physicians who perform Budenofalk therapy as described in the SPC.
- Secondary outcomeSecondary objectives include therapeutic adherence, treatment success, tolerability and safety, ease of use and pharmacy substitution.
- TimepointsTreatment duration for each patient will be decided on by the treating physician and study visits will align with the regular consultations. The study will therefore include the initial consultation (day 0 of treatment), a follow up consultation after 2 - 5 weeks, a final consultation at the end of the therapy (i.e. after 6 - 10 weeks) and a follow up safety assessment (4 weeks post last treatment dose).
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESPhD C. Koks
- CONTACT for SCIENTIFIC QUERIESMD J.J. van Ieperen
- Sponsor/Initiator Dr. Falk Pharma Benelux B.V.
- Funding
(Source(s) of Monetary or Material Support)
Dr. Falk Pharma Benelux B.V.
- Publications
- Brief summaryEuropean guidelines recommend 9 mg budesonide daily as the preferred initial therapy for mild to moderate active Crohn’s disease localized at the ileocecal region. Existing guidelines do not provide suggestions for the treatment schedule or duration, however. Though the SPCs for Budenofalk® granules and Budenofalk® capsules provide guidance, treatment schedules using these agents are generally formed by the treating physician in a case-by-case manner. Studies looking into the use of Budenofalk® in this setting have not previously been performed. Likely, different dosing schedules and treatment durations are employed for the induction of remission in Crohn’s disease patients in clinical practice. We expect these differences could have an effect on several levels; e.g. therapeutic adherence, success of therapy, patient experience, and drug tolerability.
This study has been developed to assess the use of Budenofalk® in the treatment of acute Crohn’s disease in routine clinical practice We aim to assess how Budenofalk® is used; at which dose and for how long, and how the observed differences impact the patient. Results obtained in this study will help to improve the management of Crohn’s disease.
Approximately 150 adult patients, both male and female, with endoscopically determined Crohn’s disease will be included. In accordance with the SPC, patients must be over 18 years of age at the start of the therapy. The patients will belong to the regular outpatient population of the participating physicians. They will be included in the study after an initial disease diagnosis or the diagnosis of a new flare has been made and the treating physician has decided to prescribe Budenofalk® 9 mg granules or 3 mg capsules. The prospective investigation will be carried out throughout the Netherlands.
- Main changes (audit trail)
- RECORD5-aug-2016 - 12-okt-2016


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