A Study of Pentasa in Patients With Ulcerative Colitis
- Conditions
- Ulcerative Colitis
- Registration Number
- NCT01104753
- Lead Sponsor
- Ferring Pharmaceuticals
- Brief Summary
Confirmation of safety profile of Pentasa slow release tablets 500 mg in patients with ulcerative colitis (UC).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 338
- Patients suffering from ulcerative colitis
- Hypersensitivity to mesalazine, salicylates or to any excipient
- Severe damage to liver or renal functions
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Verify the safety profile 1 year * Number of AEs/SAEs
* Intensity and seriousness of reported AEs/SAEs
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
Faculty Hospital Bpry Plzeň
🇨🇿Plzeň, Czech Republic
Faculty Hospital U Sv. Anny Brno
🇨🇿Brno, Czech Republic
Investigational site
🇨🇿České Budějovice, Czech Republic
Hospital Chrudim
🇨🇿Chrudim, Czech Republic
Faculty Hospital Olomouc
🇨🇿Olomouc, Czech Republic
Vítkovická Hospital
🇨🇿Ostrava, Czech Republic
NMSB, Praha 1
🇨🇿Praha, Czech Republic
Poliklinika Prosek, Praha
🇨🇿Praha, Czech Republic
Thomayerova hospital., Praha 4
🇨🇿Praha, Czech Republic
Hospital T. Bati Zlín
🇨🇿Zlín, Czech Republic
Hospital. Frýdek- Místek
🇨🇿Frýdek- Místek, Czech Republic
Gastromedic s.r.o.,ul.
🇨🇿Pardubice, Czech Republic
Hospital Svitavy
🇨🇿Svitavy, Czech Republic
Hospital Znojmo
🇨🇿Znojmo, Czech Republic
Hospital Karviná
🇨🇿Karviná, Czech Republic
Faculty Hospital Lochotín Plzeň
🇨🇿Plzeň, Czech Republic
Faculty Hospital Motol, Praha 5
🇨🇿Praha, Czech Republic
Hospitál Mladá Bolesl
🇨🇿Mladá Boleslav, Czech Republic
VFN, Praha 2
🇨🇿Praha, Czech Republic
Hospital Brandýs n/Lab.
🇨🇿Brandys nad Labem, Czech Republic
Hospital Břeclav
🇨🇿Břeclav, Czech Republic
ÚVN, Praha 6
🇨🇿Praha, Czech Republic
Provincial hospital, Kpt.
🇨🇿Tábor, Czech Republic