EUCTR2012-002023-15-ATActive, not recruitingPhase 1
Mesacol: The effect of mesalazine on molecular pathways ofcell adhesion in ulcerative colitis - Mesacol
Medizinische Universität Wien, Universitätsklinik für Innere Medizin 3, Abteilung für Gastroenterologie und Hepatologie0 sites12 target enrollmentStarted: September 4, 2012Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 12
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- Patients of at least 18 years of age that have consented to the study procedures and
- •have signed the informed consent form
- •- Patients with mild to moderate ulcerative colitis (as defined by the Truelove and Witts
- •criteria) who have not received 5-ASA derivates or other salicylates for the past 10 days
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
Exclusion Criteria
- •- Inability to fully comprehend and/or to perform study procedures in the investigator’s
- •- Participation in any other interventional study within 1 month prior to screening
- •- Known intolerance to 5-ASA (or its derivates) or other salicylates
- •- Intake of 5-ASA (or its derivates), any NSAIDs or COX-2 inhibitors 10 days prior to
- •- Concomitant medication with NSAIDs, COX-2 inhibitors, steroids, thiopurines, TNF-a
- •antagonists, methotrexate, calcineurin inhibitors or mycophenolate.
- •- The presence of infectious colitis
- •- Pregnancy or lactation
Investigators
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