Skip to content

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

Budenofalk granules and capsules in the treatment of active Crohn's disease - a prospective, multicenter, observational study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON24660
Enrollment
138
Registered
2016-08-05
Start date
2016-11-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease, budesonide, Budenofalk, IBD, ziekte van Crohn

Interventions

None. 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.

Sponsors

Dr. Falk Pharma Benelux B.V.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: age > 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 criteria

Exclusion criteria: have 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

Design outcomes

Primary

MeasureTime frame
The 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

MeasureTime frame
Secondary objectives include therapeutic adherence, treatment success, tolerability and safety, ease of use and pharmacy substitution.

Contacts

Public ContactC. Koks

Dr. Falk Pharma Benelux B.V.

koks@drfalkpharma-benelux.eutel. 076 - 524 42 00

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)