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Tolerability of Pentasa Sachet in Patients With Ulcerative Colitis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01517594
First received: January 20, 2012
Last updated: April 17, 2013
Last verified: April 2013
History of Changes
  Purpose

Confirmation of safety profile


Condition
Ulcerative Colitis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Tolerability of Pentasa® Sachet in Patients With Ulcerative Colitis Under Conditions of Standard Practice in the Czech Republic

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • verify the safety profile: measured by number of AEs/SAEs [ Time Frame: 12 months from patient recruitment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • dosage: evaluate dosage level [ Time Frame: 12 months from patient recruitment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 900
Study Start Date: October 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

Criteria

Inclusion Criteria:

  • treatment of Ulcerative Colitis

Exclusion Criteria:

  • hypersensitivity to mesalazine
  • severe liver or renal impairment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517594

Locations
Czech Republic
FN sv.Anna
Brno, Czech Republic
Hospital Milosrdných bratří
Brno, Czech Republic
Gastroenterologická ambulance
Brno, Czech Republic
Hospital Břeclav
Břeclav, Czech Republic
Nemocnice Cheb
Cheb, Czech Republic
Gastroenterologická ambulance Hodonín
Hodonín, Czech Republic
Hospital TGM Hodonín
Hodonín, Czech Republic
FN, II. Interní klinika
Hradec Králové, Czech Republic
Oblastní nemoncice Jičín
Jičín, Czech Republic
Nemocnice Karlovy Vary
Karlovy Vary, Czech Republic
Nemocnice s poliklinikou Ráj
Karviná, Czech Republic
Gastroenterologická ambulance Jezuitská
Litoměřice, Czech Republic
Gastroenterologická ambulance Litoměřice
Litoměřice, Czech Republic
GASTRO MED, s.r.o.
Ostrava, Czech Republic
Gastromedic s.r.o.
Pardubice, Czech Republic
4. poliklinika Plzeň, Gastroenterologická ambulance
Plzeň, Czech Republic
Ústřední vojenská nemocnice
Praha, Czech Republic
Poliklinika - gastroenterologie
Praha 1, Czech Republic
Fakultní poliklinika VFN
Praha 2, Czech Republic
Sanatorium sv. Anny
Praha 3, Czech Republic
FN Motol
Praha 5, Czech Republic
Iscare
Praha 7, Czech Republic
Poliklinika Clinicum - Interna
Praha 9, Czech Republic
Hospital Prostějov
Prostějov, Czech Republic
Poliklinika Mens
Přerov, Czech Republic
Poliklinika - gastroenterologie Rychnov nad Kněžnou
Rychnov nad Kněžnou, Czech Republic
Nemocnice Valašské Meziříčí
Valašské Meziříčí, Czech Republic
Vítkovická nemocnice
Vítkovice, Czech Republic
Krajská nemocnice T.Bati
Zlín, Czech Republic
Masarykova nemocnice,Interna
Ústí nad labem, Czech Republic
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01517594     History of Changes
Other Study ID Numbers: 000026
Study First Received: January 20, 2012
Last Updated: April 17, 2013
Health Authority: Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013