Tolerability of Pentasa Sachet in Patients With Ulcerative Colitis

Tolerability of Pentasa® Sachet in Patients With Ulcerative Colitis Under Conditions of Standard Practice in the Czech Republic

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01517594

Enrollment

568

Registered

2012-01-25

Start date

2011-10-31

Completion date

2013-06-30

Last updated

2013-10-21

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

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* treatment of Ulcerative Colitis

Exclusion criteria

* hypersensitivity to mesalazine * severe liver or renal impairment

Design outcomes

Primary

Measure	Time frame
verify the safety profile: measured by number of AEs/SAEs	12 months from patient recruitment

Secondary

Measure	Time frame
dosage: evaluate dosage level	12 months from patient recruitment

Countries

Czechia

Outcome results