Induction and Maintenance of Remission With Pentasa as Ulcerative Colitis Treatment
Information source: Ferring Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ulcerative Colitis
Intervention: mesalazine (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Ferring Pharmaceuticals Official(s) and/or principal investigator(s): Clinical Development Support, Study Director, Affiliation: Ferring Pharmaceuticals
Overall contact: Clinical Development Support, Email: DK0-Disclosure@ferring.com
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 practice, at which doses and for how long and how these differences
impact the patient disease state and work productivity.
Clinical Details
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Time to dose reduction
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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)
Locations and Contacts
Clinical Development Support, Email: DK0-Disclosure@ferring.com
Gelre Ziekenhuizen (there may be other sites in this country), Zutphen, Netherlands; Recruiting
Additional Information
Starting date: January 2015
Last updated: April 23, 2015
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