Tolerability of Pentasa Sachet in Patients With Ulcerative Colitis

October 18, 2013 updated by: Ferring Pharmaceuticals

Tolerability of Pentasa® Sachet in Patients With Ulcerative Colitis Under Conditions of Standard Practice in the Czech Republic

Confirmation of safety profile

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

568

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
      • Brno, Czech Republic
        • FN sv.Anna
      • Brno, Czech Republic
        • Gastroenterologicka ambulance
      • Brno, Czech Republic
        • Hospital Milosrdných bratří
      • Břeclav, Czech Republic
        • Hospital Břeclav
      • Cheb, Czech Republic
        • Nemocnice Cheb
      • Hodonín, Czech Republic
        • Gastroenterologická ambulance Hodonín
      • Hodonín, Czech Republic
        • Hospital TGM Hodonín
      • Hradec Králové, Czech Republic
        • FN, II. Interní klinika
      • Jičín, Czech Republic
        • Oblastní nemoncice Jičín
      • Karlovy Vary, Czech Republic
        • Nemocnice Karlovy Vary
      • Karviná, Czech Republic
        • Nemocnice s poliklinikou Ráj
      • Litoměřice, Czech Republic
        • Gastroenterologická ambulance Jezuitská
      • Litoměřice, Czech Republic
        • Gastroenterologická ambulance Litoměřice
      • Ostrava, Czech Republic
        • GASTRO MED, s.r.o.
      • Pardubice, Czech Republic
        • Gastromedic s.r.o.
      • Plzeň, Czech Republic
        • 4. poliklinika Plzeň, Gastroenterologická ambulance
      • Praha, Czech Republic
        • Ustredni vojenska nemocnice
      • Praha 1, Czech Republic
        • Poliklinika - gastroenterologie
      • Praha 2, Czech Republic
        • Fakultni Poliklinika VFN
      • Praha 3, Czech Republic
        • Sanatorium sv. Anny
      • Praha 5, Czech Republic
        • FN Motol
      • Praha 7, Czech Republic
        • Iscare
      • Praha 9, Czech Republic
        • Poliklinika Clinicum - Interna
      • Prostějov, Czech Republic
        • Hospital Prostějov
      • Přerov, Czech Republic
        • Poliklinika Mens
      • Rychnov nad Kněžnou, Czech Republic
        • Poliklinika - gastroenterologie Rychnov nad Kněžnou
      • Valašské Meziříčí, Czech Republic
        • Nemocnice Valašské Meziříčí
      • Vítkovice, Czech Republic
        • Vitkovicka nemocnice
      • Zlín, Czech Republic
        • Krajská nemocnice T.Bati
      • Ústí nad labem, Czech Republic
        • Masarykova nemocnice,Interna

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

Primary care clinic

Description

Inclusion Criteria:

  • treatment of Ulcerative Colitis

Exclusion Criteria:

  • hypersensitivity to mesalazine
  • severe liver or renal impairment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
verify the safety profile: measured by number of AEs/SAEs
Time Frame: 12 months from patient recruitment
12 months from patient recruitment

Secondary Outcome Measures

Outcome Measure
Time Frame
dosage: evaluate dosage level
Time Frame: 12 months from patient recruitment
12 months from patient recruitment

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

October 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

January 20, 2012

First Submitted That Met QC Criteria

January 20, 2012

First Posted (Estimate)

January 25, 2012

Study Record Updates

Last Update Posted (Estimate)

October 21, 2013

Last Update Submitted That Met QC Criteria

October 18, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000026

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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