Tolerability of Pentasa Sachet in Patie… | Clinical Trial

Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

FN sv.Anna, Brno, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

treatment of Ulcerative Colitis

Exclusion criteria

hypersensitivity to mesalazine
severe liver or renal impairment

Treatment and study plan

Primary outcomes

verify the safety profile: measured by number of AEs/SAEs

Time frame: 12 months from patient recruitment

Secondary outcomes

dosage: evaluate dosage level

Time frame: 12 months from patient recruitment

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Jan 25, 2012
Registry last updated: Oct 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed