Status:
COMPLETED
Induction and Maintenance of Remission With Pentasa as Ulcerative Colitis Treatment
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-70 years
Brief Summary
For both induction of remission and in maintenance of remission, different doses and treatment durations are used in practice. The aim of this study is to assess how mesalazine is used in clinical pra...
Eligibility Criteria
Inclusion
- Patients with mild to moderate active ulcerative colitis with disease extension beyond the rectum (≥ 10 cm) who will receive oral Pentasa treatment (Compact sachets and/or tablets) for the treatment of the current active episode or in whom on oral Pentasa maintenance treatment induction of remission treatment will be initiated by dose escalation. Treatment combined with Pentasa enema (1g/100ml) is allowed.
- Informed consent
Exclusion
- Patients receiving treatment with one or more of the following: locally acting steroids (e.g. budesonide, beclomethasone), systemic steroids, immunosuppressants (e.g. thiopurines), biologicals (e.g. anti-Tumor Necrosis Factor-alpha)
Key Trial Info
Start Date :
January 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 14 2019
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT02261636
Start Date
January 1 2015
End Date
January 14 2019
Last Update
May 20 2022
Active Locations (1)
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1
Gelre Ziekenhuizen (there may be other sites in this country)
Zutphen, Netherlands