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A Study of Pentasa in Patients With Ulcerative Colitis

NCT ID: NCT01104753

Last Updated: 2011-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

338 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-03-31

Brief Summary

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

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Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Non-interventional post-authorisation safety study

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients suffering from ulcerative colitis

Exclusion Criteria

* Hypersensitivity to mesalazine, salicylates or to any excipient
* Severe damage to liver or renal functions
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ferring Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Ferring Pharmaceuticals

Principal Investigators

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Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

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Hospital Brandýs n/Lab.

Brandýs nad Labem, , Czechia

Site Status

Faculty Hospital U Sv. Anny Brno

Brno, , Czechia

Site Status

Hospital Břeclav

Břeclav, , Czechia

Site Status

Investigational site

Chomutov, , Czechia

Site Status

Hospital Chrudim

Chrudim, , Czechia

Site Status

Investigational site

České Budějovice, , Czechia

Site Status

Hospital Karviná

Fryštát, , Czechia

Site Status

Hospital. Frýdek- Místek

Frýdek-Místek, , Czechia

Site Status

Investigational site

Hodonín, , Czechia

Site Status

Investigational site

Hradec Králové, , Czechia

Site Status

Investigational site

Litoměřice, , Czechia

Site Status

Hospitál Mladá Bolesl

Mladá Boleslav, , Czechia

Site Status

Faculty Hospital Olomouc

Olomouc, , Czechia

Site Status

Investigational site

Ostrava, , Czechia

Site Status

Vítkovická Hospital

Ostrava, , Czechia

Site Status

Gastromedic s.r.o.,ul.

Pardubice, , Czechia

Site Status

Faculty Hospital Bpry Plzeň

Pilsen, , Czechia

Site Status

Faculty Hospital Lochotín Plzeň

Pilsen, , Czechia

Site Status

Faculty Hospital Motol, Praha 5

Prague, , Czechia

Site Status

NMSB, Praha 1

Prague, , Czechia

Site Status

Poliklinika Prosek, Praha

Prague, , Czechia

Site Status

Thomayerova hospital., Praha 4

Prague, , Czechia

Site Status

VFN, Praha 2

Prague, , Czechia

Site Status

ÚVN, Praha 6

Prague, , Czechia

Site Status

Investigational site

Přerov, , Czechia

Site Status

Hospital Svitavy

Svitavy, , Czechia

Site Status

Provincial hospital, Kpt.

Tábor, , Czechia

Site Status

Investigational site

Ústí n.Labem, , Czechia

Site Status

Hospital T. Bati Zlín

Zlín, , Czechia

Site Status

Hospital Znojmo

Znojmo, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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FE999907 CS07

Identifier Type: -

Identifier Source: org_study_id

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