Budenofalk granules and capsules in the treatment of Crohn's disease
- Conditions
- Crohn's disease, budesonide, Budenofalk, IBD, ziekte van Crohn
- Registration Number
- NL-OMON24660
- Lead Sponsor
- Dr. Falk Pharma Benelux B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 138
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;
Exclusion Criteria
have severe active Crohn's disease;
are being treated with corticosteroids for current flare;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary objectives include therapeutic adherence, treatment success, tolerability and safety, ease of use and pharmacy substitution.