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
1 other identifier
observational
568
1 country
30
Brief Summary
Confirmation of safety profile
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2011
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
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 20, 2012
CompletedFirst Posted
Study publicly available on registry
January 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedOctober 21, 2013
October 1, 2013
1.7 years
January 20, 2012
October 18, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
verify the safety profile: measured by number of AEs/SAEs
12 months from patient recruitment
Secondary Outcomes (1)
dosage: evaluate dosage level
12 months from patient recruitment
Eligibility Criteria
Primary care clinic
You may qualify if:
- treatment of Ulcerative Colitis
You may not qualify if:
- hypersensitivity to mesalazine
- severe liver or renal impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
FN sv.Anna
Brno, Czechia
Gastroenterologická ambulance
Brno, Czechia
Hospital Milosrdných bratří
Brno, Czechia
Hospital Břeclav
Břeclav, Czechia
Nemocnice Cheb
Cheb, Czechia
Nemocnice s poliklinikou Ráj
Fryštát, Czechia
Gastroenterologická ambulance Hodonín
Hodonín, Czechia
Hospital TGM Hodonín
Hodonín, Czechia
FN, II. Interní klinika
Hradec Králové, Czechia
Oblastní nemoncice Jičín
Jičín, Czechia
Nemocnice Karlovy Vary
Karlovy Vary, Czechia
Gastroenterologická ambulance Jezuitská
Litoměřice, Czechia
Gastroenterologická ambulance Litoměřice
Litoměřice, Czechia
GASTRO MED, s.r.o.
Ostrava, Czechia
Gastromedic s.r.o.
Pardubice, Czechia
4. poliklinika Plzeň, Gastroenterologická ambulance
Pilsen, Czechia
Fakultní poliklinika VFN
Prague, Czechia
FN Motol
Prague, Czechia
Iscare
Prague, Czechia
Poliklinika - gastroenterologie
Prague, Czechia
Poliklinika Clinicum - Interna
Prague, Czechia
Sanatorium sv. Anny
Prague, Czechia
Ústřední vojenská nemocnice
Prague, Czechia
Hospital Prostějov
Prostějov, Czechia
Poliklinika Mens
Přerov, Czechia
Poliklinika - gastroenterologie Rychnov nad Kněžnou
Rychnov nad Kněžnou, Czechia
Masarykova nemocnice,Interna
Ústí nad Labem, Czechia
Nemocnice Valašské Meziříčí
Valašské Meziříčí, Czechia
Vítkovická nemocnice
Vítkovice, Czechia
Krajská nemocnice T.Bati
Zlín, 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
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2012
First Posted
January 25, 2012
Study Start
October 1, 2011
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
October 21, 2013
Record last verified: 2013-10