Tolerability of Pentasa Sachet in Patients With Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01517594
Recruitment Status : Completed
First Posted : January 25, 2012
Last Update Posted : October 21, 2013
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Brief Summary:
Confirmation of safety profile

Condition or disease
Ulcerative Colitis

Study Type : Observational
Actual Enrollment : 568 participants
Time Perspective: Prospective
Official Title: Tolerability of Pentasa® Sachet in Patients With Ulcerative Colitis Under Conditions of Standard Practice in the Czech Republic
Study Start Date : October 2011
Primary Completion Date : June 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. verify the safety profile: measured by number of AEs/SAEs [ Time Frame: 12 months from patient recruitment ]

Secondary Outcome Measures :
  1. dosage: evaluate dosage level [ Time Frame: 12 months from patient recruitment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic

Inclusion Criteria:

  • treatment of Ulcerative Colitis

Exclusion Criteria:

  • hypersensitivity to mesalazine
  • severe liver or renal impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01517594

Czech Republic
FN sv.Anna
Brno, Czech Republic
Gastroenterologická ambulance
Brno, Czech Republic
Hospital Milosrdných bratří
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
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
Praha 7, Czech Republic
Poliklinika Clinicum - Interna
Praha 9, Czech Republic
Ústřední vojenská nemocnice
Praha, 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
Study Director: Clinical Development Support Ferring Pharmaceuticals

Responsible Party: Ferring Pharmaceuticals Identifier: NCT01517594     History of Changes
Other Study ID Numbers: 000026
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: October 21, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents