Clinical trial NCT01517594: Tolerability of Pentasa Sachet in Patients With Ulcerative Colitis
Official title: Tolerability of Pentasa® Sachet in Patients With Ulcerative Colitis Under Conditions of Standard Practice in the Czech Republic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-01-25
Enrollment: 568
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: Confirmation of safety profile


Eligibility criteria: Inclusion Criteria:

* treatment of Ulcerative Colitis

Exclusion Criteria:

* hypersensitivity to mesalazine
* severe liver or renal impairment

Primary outcomes:
measure: verify the safety profile: measured by number of AEs/SAEs
timeFrame: 12 months from patient recruitment
Secondary outcomes:
measure: dosage: evaluate dosage level
timeFrame: 12 months from patient recruitment
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: FN sv.Anna
city: Brno
country: Czech Republic
facility: Gastroenterologická ambulance
city: Brno
country: Czech Republic
facility: Hospital Milosrdných bratří
city: Břeclav
country: Czech Republic
facility: Hospital Břeclav
city: Cheb
country: Czech Republic
facility: Nemocnice Cheb
city: Hodonín
country: Czech Republic
facility: Gastroenterologická ambulance Hodonín
city: Hodonín
country: Czech Republic
facility: Hospital TGM Hodonín
city: Hradec Králové
country: Czech Republic
facility: FN, II. Interní klinika
city: Jičín
country: Czech Republic
facility: Oblastní nemoncice Jičín
city: Karlovy Vary
country: Czech Republic
facility: Nemocnice Karlovy Vary
city: Karviná
country: Czech Republic
facility: Nemocnice s poliklinikou Ráj
city: Litoměřice
country: Czech Republic
facility: Gastroenterologická ambulance Jezuitská
city: Litoměřice
country: Czech Republic
facility: Gastroenterologická ambulance Litoměřice
city: Ostrava
country: Czech Republic
facility: GASTRO MED, s.r.o.
city: Pardubice
country: Czech Republic
facility: Gastromedic s.r.o.
city: Plzeň
country: Czech Republic
facility: 4. poliklinika Plzeň, Gastroenterologická ambulance
city: Praha 1
country: Czech Republic
facility: Poliklinika - gastroenterologie
city: Praha 2
country: Czech Republic
facility: Fakultní poliklinika VFN
city: Praha 3
country: Czech Republic
facility: Sanatorium sv. Anny
city: Praha 5
country: Czech Republic
facility: FN Motol
city: Praha 7
country: Czech Republic
facility: Iscare
city: Praha 9
country: Czech Republic
facility: Poliklinika Clinicum - Interna
city: Praha
country: Czech Republic
facility: Ústřední vojenská nemocnice
city: Prostějov
country: Czech Republic
facility: Hospital Prostějov
city: Přerov
country: Czech Republic
facility: Poliklinika Mens
city: Rychnov nad Kněžnou
country: Czech Republic
facility: Poliklinika - gastroenterologie Rychnov nad Kněžnou
city: Valašské Meziříčí
country: Czech Republic
facility: Nemocnice Valašské Meziříčí
city: Vítkovice
country: Czech Republic
facility: Vítkovická nemocnice
city: Zlín
country: Czech Republic
facility: Krajská nemocnice T.Bati
city: Ústí nad labem
country: Czech Republic
facility: Masarykova nemocnice,Interna
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: