Crohn's DiseaseCrohn 2NCT01363427
Retrospective Data Analysis in Crohn's Disease
An observational study of Crohn's Disease, run by Ferring Pharmaceuticals at 16 sites in Germany.
Trial summary
The purpose of this study is to identify prognostic parameters about efficacy of Mesalazine in recently diagnosed patients with Morbus Crohn by retrospective data collection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- How many people
- 161 participants
- Where
- 16 sitesGermany
- Study dates
- Mar 2007to Jul 2010
- 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: Private practices
Who may be able to join
- therapeutic need according to SPC
- written informed consent
Who cannot join
None listed.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Germany16 sites
Investigational Site, Ehrenfelsstraße 47
Berlin
Investigational Site, Möllendorfstraße 111
Berlin
Investigational Site, Graseggerstraße 105
Cologne
Investigational Site, Münchner Straße 64
Dachau
Investigational Site, Karlsbader Straße 7
Dinkelsbühl
Investigational Site, Heiligengrabstraße 16
Hof
Investigational Site, Am Tiefen Weg 2
Karlstadt am Main
Investigational Site, Erdbeerfeld 8
Kiel-Altenholz
Investigational Site, Hohenfelder Straße 20
Koblenz
Investigational Site, Funkenburgstraße 19
Leipzig
Investigational Site, Franz-Kail-Straße 2
Leverkusen
Investigational Site, Bahnhofplatz 2
Mainz
Investigational Site, Uferstraße 3
Minden
Investigational Site, Hammer Straße 95
Münster
Investigational Site, Weiltinger Str. 11
Nuremberg
Investigational Site, Marktplatz 23
Rottenburg
About this study
Official title: Retrospective Data Analysis of Newly Diagnosed Crohn's Disease Patients in Gastroenterological Surgeries
The purpose of this study is to identify prognostic parameters about efficacy of Mesalazine in recently diagnosed patients with Morbus Crohn by retrospective data collection.
- Conditions
- Crohn's Disease
- Medical subject headings
- Crohn Disease
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 |
|---|---|---|
| Crohn's disease | Patients with initially diagnosed Crohn's disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to Mesalazine: measured by time to step up therapy
Measured: 12 to 48 months
Secondary outcomes (1)
Identification and characterisation of the responding sub-population
measured by: (a) Age at diagnosis, (b) Proportion of patients with minor endoscopic lesions, (c) Lack of severe mucosal lesions (Adapted Rutgeerts Score < 2)
Measured: 12 to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2011 (estimated)
- Study startMar 2007
- Primary completionMay 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies 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
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 161 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
- NCT01363427
- Sponsor's protocol ID
- FE 999907 (Pentasa)
- Acronym
- Crohn 2
- Status last verified
- May 2011
- First submitted
- 30 May 2011
- Last updated
- 1 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Data Analysis of Newly Diagnosed Crohn's Disease Patients in Gastroenterological Surgeries
- ClinicalTrials.gov ID
- NCT01363427
- Acronym / sponsor ID
- Crohn 2 / FE 999907 (Pentasa)
- Conditions
- Crohn's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- May 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 1 Jun 2011 (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.
The purpose of this study is to identify prognostic parameters about efficacy of Mesalazine in recently diagnosed patients with Morbus Crohn by retrospective data collection.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Crohn's disease | – | –Patients with initially diagnosed Crohn's disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Private practices
Key inclusion criteria (2 listed)
- therapeutic need according to SPC
- written informed consent
Key exclusion criteria (0 listed)
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
Response to Mesalazine: measured by time to step up therapy
Time frame: 12 to 48 months
1 secondary outcome
Identification and characterisation of the responding sub-population
Time frame: 12 to 48 months
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 1 Jun 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
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by Ferring Pharmaceuticals at 16 sites in Germany.
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 2 inclusion and 0 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 1 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Germany. 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?
Response to Mesalazine: measured by time to step up therapy (time frame: 12 to 48 months). 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 1 Jun 2011.