CClinicalTrials.gg
CompletedNCT01104753Updated Apr 7, 2011

A Study of Pentasa in Patients With Ulcerative Colitis

An observational study in Ulcerative Colitis, sponsored by Ferring Pharmaceuticals. Completed at 30 sites in Czech Republic. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-04-07.

Sponsored by Ferring Pharmaceuticals · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
338
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Ulcerative Colitis
03

In context

Colitis

1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.

This study's enrollment of 338 is above the median of 105 across 247 observational studies indexed under Colitis.

Browse Colitis studies →

Lead sponsor

Ferring Pharmaceuticals is the lead sponsor of 244 studies on the registry; 4 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 13 (93%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Hypersensitivity to mesalazine, salicylates or to any excipient
  • Severe damage to liver or renal functions
05

Study design

Time perspective
Prospective
Enrollment
338 participants (actual)

Groups and cohorts

  • Non-interventional post-authorisation safety study
06

What researchers measure

Primary outcomes

  1. Verify the safety profile

    * Number of AEs/SAEs * Intensity and seriousness of reported AEs/SAEs

    Time frame: 1 year

07

Study locations

30 sites
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01104753
Lead sponsor
Ferring Pharmaceuticals
First posted
Apr 15, 2010
Start date
Sep 2009
Primary completion
Oct 2010
Completion
Mar 2011
Last update
Apr 7, 2011

Study contacts

Clinical Development Support
study director · Ferring Pharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

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