Ulcerative ColitisNCT01104753
A Study of Pentasa in Patients With Ulcerative Colitis
An observational study of Ulcerative Colitis, run by Ferring Pharmaceuticals at 30 sites in Czechia.
Trial summary
Confirmation of safety profile of Pentasa slow release tablets 500 mg in patients with ulcerative colitis (UC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- How many people
- 338 participants
- Where
- 30 sitesCzechia
- Study dates
- Sep 2009to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from ulcerative colitis
Who may be able to join
- Patients suffering from ulcerative colitis
Who cannot join
- Hypersensitivity to mesalazine, salicylates or to any excipient
- Severe damage to liver or renal functions
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
Czechia30 sites
Hospital Brandýs n/Lab.
Brandýs nad Labem
Hospital Břeclav
Břeclav
Faculty Hospital U Sv. Anny Brno
Brno
Investigational site
České Budějovice
Investigational site
Chomutov
Hospital Chrudim
Chrudim
Hospital. Frýdek- Místek
Frýdek-Místek
Hospital Karviná
Fryštát
Investigational site
Hodonín
Investigational site
Hradec Králové
Investigational site
Litoměřice
Hospitál Mladá Bolesl
Mladá Boleslav
Faculty Hospital Olomouc
Olomouc
Investigational site
Ostrava
Vítkovická Hospital
Ostrava
Gastromedic s.r.o.,ul.
Pardubice
Faculty Hospital Bpry Plzeň
Pilsen
Faculty Hospital Lochotín Plzeň
Pilsen
Faculty Hospital Motol, Praha 5
Prague
NMSB, Praha 1
Prague
Poliklinika Prosek, Praha
Prague
Thomayerova hospital., Praha 4
Prague
VFN, Praha 2
Prague
ÚVN, Praha 6
Prague
Investigational site
Přerov
Hospital Svitavy
Svitavy
Provincial hospital, Kpt.
Tábor
Investigational site
Ústí n.Labem
Hospital T. Bati Zlín
Zlín
Hospital Znojmo
Znojmo
About this study
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
Confirmation of safety profile of Pentasa slow release tablets 500 mg in patients with ulcerative colitis (UC).
- Conditions
- Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-interventional post-authorisation safety study | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verify the safety profile
- Number of AEs/SAEs
- Intensity and seriousness of reported AEs/SAEs
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startSep 2009
- Primary completionOct 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104753
- Sponsor's protocol ID
- FE999907 CS07
- Status last verified
- Apr 2011
- First submitted
- 26 Mar 2010
- Last updated
- 7 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01104753
- Acronym / sponsor ID
- FE999907 CS07
- Conditions
- Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 15 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Confirmation of safety profile of Pentasa slow release tablets 500 mg in patients with ulcerative colitis (UC).
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-interventional post-authorisation safety study | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from ulcerative colitis
Key inclusion criteria (1 listed)
- Patients suffering from ulcerative colitis
Key exclusion criteria (2 listed)
- Hypersensitivity to mesalazine, salicylates or to any excipient
- Severe damage to liver or renal functions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Verify the safety profile
Time frame: 1 year
* Number of AEs/SAEs * Intensity and seriousness of reported AEs/SAEs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development Support study director
Ferring Pharmaceuticals
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by Ferring Pharmaceuticals at 30 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verify the safety profile (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2011.