A Study of Pentasa 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: NCT01104753
Recruitment Status : Completed
First Posted : April 15, 2010
Last Update Posted : April 7, 2011
Information provided by:
Ferring Pharmaceuticals

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

Condition or disease
Ulcerative Colitis

Study Type : Observational
Actual Enrollment : 338 participants
Time Perspective: Prospective
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 Start Date : September 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Non-interventional post-authorisation safety study

Primary Outcome Measures :
  1. Verify the safety profile [ Time Frame: 1 year ]
    • Number of AEs/SAEs
    • Intensity and seriousness of reported AEs/SAEs

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
Patients suffering from ulcerative colitis

Inclusion Criteria:

  • Patients suffering from ulcerative colitis

Exclusion Criteria:

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

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): NCT01104753

Czech Republic
Hospital Brandýs n/Lab.
Brandys nad Labem, Czech Republic
Faculty Hospital U Sv. Anny Brno
Brno, Czech Republic
Hospital Břeclav
Břeclav, Czech Republic
Investigational site
Chomutov, Czech Republic
Hospital Chrudim
Chrudim, Czech Republic
Hospital. Frýdek- Místek
Frýdek- Místek, Czech Republic
Investigational site
Hodonín, Czech Republic
Investigational site
Hradec Králové, Czech Republic
Hospital Karviná
Karviná, Czech Republic
Investigational site
Litoměřice, Czech Republic
Hospitál Mladá Bolesl
Mladá Boleslav, Czech Republic
Faculty Hospital Olomouc
Olomouc, Czech Republic
Investigational site
Ostrava, Czech Republic
Vítkovická Hospital
Ostrava, Czech Republic
Gastromedic s.r.o.,ul.
Pardubice, Czech Republic
Faculty Hospital Bpry Plzeň
Plzeň, Czech Republic
Faculty Hospital Lochotín Plzeň
Plzeň, Czech Republic
Faculty Hospital Motol, Praha 5
Praha, Czech Republic
NMSB, Praha 1
Praha, Czech Republic
Poliklinika Prosek, Praha
Praha, Czech Republic
Thomayerova hospital., Praha 4
Praha, Czech Republic
VFN, Praha 2
Praha, Czech Republic
ÚVN, Praha 6
Praha, Czech Republic
Investigational site
Přerov, Czech Republic
Hospital Svitavy
Svitavy, Czech Republic
Provincial hospital, Kpt.
Tábor, Czech Republic
Hospital T. Bati Zlín
Zlín, Czech Republic
Hospital Znojmo
Znojmo, Czech Republic
Investigational site
Ústí n.Labem, Czech Republic
Investigational site
České Budějovice, Czech Republic
Sponsors and Collaborators
Ferring Pharmaceuticals
Study Director: Clinical Development Support Ferring Pharmaceuticals

Responsible Party: Clinical Development Support, Ferring Pharmaceuticals Identifier: NCT01104753     History of Changes
Other Study ID Numbers: FE999907 CS07
First Posted: April 15, 2010    Key Record Dates
Last Update Posted: April 7, 2011
Last Verified: April 2011

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