Ulcerative ColitisNCT01517594
Tolerability of Pentasa Sachet 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- How many people
- 568 participants
- Where
- 30 sitesCzechia
- Study dates
- Oct 2011to Jun 2013
- 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: Primary care clinic
Who may be able to join
- treatment of Ulcerative Colitis
Who cannot join
- hypersensitivity to mesalazine
- severe liver or renal impairment
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
Czechia30 sites
Hospital Břeclav
Břeclav
FN sv.Anna
Brno
Gastroenterologická ambulance
Brno
Hospital Milosrdných bratří
Brno
Nemocnice Cheb
Cheb
Nemocnice s poliklinikou Ráj
Fryštát
Gastroenterologická ambulance Hodonín
Hodonín
Hospital TGM Hodonín
Hodonín
FN, II. Interní klinika
Hradec Králové
Oblastní nemoncice Jičín
Jičín
Nemocnice Karlovy Vary
Karlovy Vary
Gastroenterologická ambulance Jezuitská
Litoměřice
Gastroenterologická ambulance Litoměřice
Litoměřice
GASTRO MED, s.r.o.
Ostrava
Gastromedic s.r.o.
Pardubice
4. poliklinika Plzeň, Gastroenterologická ambulance
Pilsen
Fakultní poliklinika VFN
Prague
FN Motol
Prague
Iscare
Prague
Poliklinika - gastroenterologie
Prague
Poliklinika Clinicum - Interna
Prague
Sanatorium sv. Anny
Prague
Ústřední vojenská nemocnice
Prague
Poliklinika Mens
Přerov
Hospital Prostějov
Prostějov
Poliklinika - gastroenterologie Rychnov nad Kněžnou
Rychnov nad Kněžnou
Masarykova nemocnice,Interna
Ústí nad Labem
Nemocnice Valašské Meziříčí
Valašské Meziříčí
Vítkovická nemocnice
Vítkovice
Krajská nemocnice T.Bati
Zlín
About this study
Official title: Tolerability of Pentasa® Sachet in Patients With Ulcerative Colitis Under Conditions of Standard Practice in the Czech Republic
Confirmation of safety profile
- Conditions
- Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative
What is being measured
The primary outcome is the main question the study is designed to answer.
verify the safety profile: measured by number of AEs/SAEs
Measured: 12 months from patient recruitment
Secondary outcomes (1)
dosage: evaluate dosage level
Measured: 12 months from patient recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startOct 2011
- Primary completionJun 2013
- Study completionJun 2013
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
- 568 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01517594
- Sponsor's protocol ID
- 000026
- Status last verified
- Oct 2013
- First submitted
- 20 Jan 2012
- Last updated
- 21 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability of Pentasa® Sachet in Patients With Ulcerative Colitis Under Conditions of Standard Practice in the Czech Republic
- ClinicalTrials.gov ID
- NCT01517594
- Acronym / sponsor ID
- 000026
- Conditions
- Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 568 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 25 Jan 2012 (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
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (1 listed)
- treatment of Ulcerative Colitis
Key exclusion criteria (2 listed)
- hypersensitivity to mesalazine
- severe liver or renal impairment
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: measured by number of AEs/SAEs
Time frame: 12 months from patient recruitment
1 secondary outcome
dosage: evaluate dosage level
Time frame: 12 months from patient recruitment
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 21 Oct 2013.
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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 21 Oct 2013. 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: measured by number of AEs/SAEs (time frame: 12 months from patient recruitment). 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 21 Oct 2013.