Clinical trial NCT01104753: A Study of Pentasa in Patients With Ulcerative Colitis
Official title: Non-interventional Post Marketing Safety Study Confirming Efficacy and Safety of Pentasa Slow Release Tablets in Patients With Ulcerative Colitis in Common Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-04-15
Enrollment: 338
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: Patients suffering from ulcerative colitis

Brief summary: Confirmation of safety profile of Pentasa slow release tablets 500 mg in patients with ulcerative colitis (UC).


Eligibility criteria: Inclusion Criteria:

* Patients suffering from ulcerative colitis

Exclusion Criteria:

* Hypersensitivity to mesalazine, salicylates or to any excipient
* Severe damage to liver or renal functions

Primary outcomes:
measure: Verify the safety profile
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Brandys nad Labem
country: Czech Republic
facility: Hospital Brandýs n/Lab.
city: Brno
country: Czech Republic
facility: Faculty Hospital U Sv. Anny Brno
city: Břeclav
country: Czech Republic
facility: Hospital Břeclav
city: Chomutov
country: Czech Republic
facility: Investigational site
city: Chrudim
country: Czech Republic
facility: Hospital Chrudim
city: Frýdek- Místek
country: Czech Republic
facility: Hospital. Frýdek- Místek
city: Hodonín
country: Czech Republic
facility: Investigational site
city: Hradec Králové
country: Czech Republic
facility: Investigational site
city: Karviná
country: Czech Republic
facility: Hospital Karviná
city: Litoměřice
country: Czech Republic
facility: Investigational site
city: Mladá Boleslav
country: Czech Republic
facility: Hospitál Mladá Bolesl
city: Olomouc
country: Czech Republic
facility: Faculty Hospital Olomouc
city: Ostrava
country: Czech Republic
facility: Investigational site
city: Ostrava
country: Czech Republic
facility: Vítkovická Hospital
city: Pardubice
country: Czech Republic
facility: Gastromedic s.r.o.,ul.
city: Plzeň
country: Czech Republic
facility: Faculty Hospital Bpry Plzeň
city: Plzeň
country: Czech Republic
facility: Faculty Hospital Lochotín Plzeň
city: Praha
country: Czech Republic
facility: Faculty Hospital Motol, Praha 5
city: Praha
country: Czech Republic
facility: NMSB, Praha 1
city: Praha
country: Czech Republic
facility: Poliklinika Prosek, Praha
city: Praha
country: Czech Republic
facility: Thomayerova hospital., Praha 4
city: Praha
country: Czech Republic
facility: VFN, Praha 2
city: Praha
country: Czech Republic
facility: ÚVN, Praha 6
city: Přerov
country: Czech Republic
facility: Investigational site
city: Svitavy
country: Czech Republic
facility: Hospital Svitavy
city: Tábor
country: Czech Republic
facility: Provincial hospital, Kpt.
city: Zlín
country: Czech Republic
facility: Hospital T. Bati Zlín
city: Znojmo
country: Czech Republic
facility: Hospital Znojmo
city: Ústí n.Labem
country: Czech Republic
facility: Investigational site
city: České Budějovice
country: Czech Republic
facility: Investigational site
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: