A Study of Pentasa in Patients With Ulcerative Colitis

Non-interventional Post Marketing Safety Study Confirming Efficacy and Safety of Pentasa Slow Release Tablets in Patients With Ulcerative Colitis in Common Clinical Practice

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01104753

Enrollment

338

Registered

2010-04-15

Start date

2009-09-30

Completion date

2011-03-31

Last updated

2011-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Brief summary

Confirmation of safety profile of Pentasa slow release tablets 500 mg in patients with ulcerative colitis (UC).

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients suffering from ulcerative colitis

Exclusion criteria

* Hypersensitivity to mesalazine, salicylates or to any excipient * Severe damage to liver or renal functions

Design outcomes

Primary

Measure	Time frame	Description
Verify the safety profile	1 year	* Number of AEs/SAEs * Intensity and seriousness of reported AEs/SAEs

Countries

Czechia

Outcome results