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
1 other identifier
observational
338
1 country
30
Brief Summary
Confirmation of safety profile of Pentasa slow release tablets 500 mg in patients with ulcerative colitis (UC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2009
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 26, 2010
CompletedFirst Posted
Study publicly available on registry
April 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedApril 7, 2011
April 1, 2011
1.1 years
March 26, 2010
April 6, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Verify the safety profile
* Number of AEs/SAEs * Intensity and seriousness of reported AEs/SAEs
1 year
Study Arms (1)
Non-interventional post-authorisation safety study
Eligibility Criteria
Patients suffering from ulcerative colitis
You may qualify if:
- Patients suffering from ulcerative colitis
You may not qualify if:
- Hypersensitivity to mesalazine, salicylates or to any excipient
- Severe damage to liver or renal functions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Hospital Brandýs n/Lab.
Brandýs nad Labem, Czechia
Faculty Hospital U Sv. Anny Brno
Brno, Czechia
Hospital Břeclav
Břeclav, Czechia
Investigational site
Chomutov, Czechia
Hospital Chrudim
Chrudim, Czechia
Investigational site
České Budějovice, Czechia
Hospital Karviná
Fryštát, Czechia
Hospital. Frýdek- Místek
Frýdek-Místek, Czechia
Investigational site
Hodonín, Czechia
Investigational site
Hradec Králové, Czechia
Investigational site
Litoměřice, Czechia
Hospitál Mladá Bolesl
Mladá Boleslav, Czechia
Faculty Hospital Olomouc
Olomouc, Czechia
Investigational site
Ostrava, Czechia
Vítkovická Hospital
Ostrava, Czechia
Gastromedic s.r.o.,ul.
Pardubice, Czechia
Faculty Hospital Bpry Plzeň
Pilsen, Czechia
Faculty Hospital Lochotín Plzeň
Pilsen, Czechia
Faculty Hospital Motol, Praha 5
Prague, Czechia
NMSB, Praha 1
Prague, Czechia
Poliklinika Prosek, Praha
Prague, Czechia
Thomayerova hospital., Praha 4
Prague, Czechia
VFN, Praha 2
Prague, Czechia
ÚVN, Praha 6
Prague, Czechia
Investigational site
Přerov, Czechia
Hospital Svitavy
Svitavy, Czechia
Provincial hospital, Kpt.
Tábor, Czechia
Investigational site
Ústí n.Labem, Czechia
Hospital T. Bati Zlín
Zlín, Czechia
Hospital Znojmo
Znojmo, Czechia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 26, 2010
First Posted
April 15, 2010
Study Start
September 1, 2009
Primary Completion
October 1, 2010
Study Completion
March 1, 2011
Last Updated
April 7, 2011
Record last verified: 2011-04