NCT01104753CompletedNot Applicable
Non-interventional Post Marketing Safety Study Confirming Efficacy and Safety of Pentasa Slow Release Tablets in Patients With Ulcerative Colitis in Common Clinical Practice
Ferring Pharmaceuticals23 sites in 1 country338 target enrollmentStarted: September 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ferring Pharmaceuticals
- Enrollment
- 338
- Locations
- 23
- Primary Endpoint
- Verify the safety profile
Study Overview
Brief Summary
Confirmation of safety profile of Pentasa slow release tablets 500 mg in patients with ulcerative colitis (UC).
Study Design
- Study Type
- Observational
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients suffering from ulcerative colitis
Exclusion Criteria
- •Hypersensitivity to mesalazine, salicylates or to any excipient
- •Severe damage to liver or renal functions
Outcomes
Primary Outcomes
Verify the safety profile
Time Frame: 1 year
* Number of AEs/SAEs * Intensity and seriousness of reported AEs/SAEs
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (23)
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