A Study of Pentasa in Patients With Ulcerative Colitis

April 6, 2011 updated by: Ferring Pharmaceuticals

Non-interventional Post Marketing Safety Study Confirming Efficacy and Safety of Pentasa Slow Release Tablets in Patients With Ulcerative Colitis in Common Clinical Practice

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

338

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Brandys nad Labem, Czech Republic
        • Hospital Brandýs n/Lab.
      • Brno, Czech Republic
        • Faculty Hospital U Sv. Anny Brno
      • Břeclav, Czech Republic
        • Hospital Břeclav
      • Chomutov, Czech Republic
        • Investigational Site
      • Chrudim, Czech Republic
        • Hospital Chrudim
      • Frýdek- Místek, Czech Republic
        • Hospital. Frýdek- Místek
      • Hodonín, Czech Republic
        • Investigational Site
      • Hradec Králové, Czech Republic
        • Investigational Site
      • Karviná, Czech Republic
        • Hospital Karviná
      • Litoměřice, Czech Republic
        • Investigational Site
      • Mladá Boleslav, Czech Republic
        • Hospitál Mladá Bolesl
      • Olomouc, Czech Republic
        • Faculty Hospital Olomouc
      • Ostrava, Czech Republic
        • Investigational Site
      • Ostrava, Czech Republic
        • Vítkovická Hospital
      • Pardubice, Czech Republic
        • Gastromedic s.r.o.,ul.
      • Plzeň, Czech Republic
        • Faculty Hospital Bpry Plzeň
      • Plzeň, Czech Republic
        • Faculty Hospital Lochotín Plzeň
      • Praha, 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
      • Přerov, Czech Republic
        • Investigational Site
      • Svitavy, Czech Republic
        • Hospital Svitavy
      • Tábor, Czech Republic
        • Provincial hospital, Kpt.
      • Zlín, Czech Republic
        • Hospital T. Bati Zlín
      • Znojmo, Czech Republic
        • Hospital Znojmo
      • Ústí n.Labem, Czech Republic
        • Investigational Site
      • České Budějovice, Czech Republic
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients suffering from ulcerative colitis

Description

Inclusion Criteria:

  • Patients suffering from ulcerative colitis

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Non-interventional post-authorisation safety study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Verify the safety profile
Time Frame: 1 year
  • Number of AEs/SAEs
  • Intensity and seriousness of reported AEs/SAEs
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

March 26, 2010

First Submitted That Met QC Criteria

April 14, 2010

First Posted (Estimate)

April 15, 2010

Study Record Updates

Last Update Posted (Estimate)

April 7, 2011

Last Update Submitted That Met QC Criteria

April 6, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FE999907 CS07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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