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Ulcerative ColitisMUKOSANCT01517607

Mesalazine (PENTASA®) in Ulcerative Colitis

An observational study of Ulcerative Colitis, run by Ferring Pharmaceuticals at 149 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This non-interventional study examines whether the patient's level of information and the consideration of the patient's preference have a positive effect on the compliance and thus also on the therapeutic success. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ulcerative Colitis
What is being tested?
Mesalazine
Type of treatment
Pill or oral medicine
How many people
506 participants
Where
149 sitesGermany
Study dates
Feb 2012to Dec 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 facilities

Who may be able to join

  • Patients are treated for the first time with oral PENTASA®, e.g. following first diagnosis of ulcerative colitis for treatment of an acute episode or
  • Following a therapy-free period (no previous mesalazine therapy) or due to poor response or underdosage oder lacking acceptance of the previous medication the patients are re-adjusted to oral PENTASA®,
  • The patients (≥ 18 years) have been informed about the NIS and have given their written consent for participation.

Who cannot join

None listed.

Trial locations and contacts

149 sites in 1 country.

149 sites in 1 country

Germany149 sites

  • Investigational site, Wettinerstraße 22

    Altenburg

  • Investigational site, Marienstraße 6

    Amberg

  • Investigational site, Adam-Ries-Straße 57c

    Annaberg-Buchholz

  • Investigational site, Goethestraße 5

    Ansbach

  • Investigational site, Elisenstraße 32

    Aschaffenburg

  • Investigational site, Prinzregentenstraße 8

    Augsburg

  • Investigational site, Koblenzer Straße 37

    Bad Godesberg

  • Investigational site, Goethestraße 15g

    Bad Neustadt an der Saale

  • Investigational site, Töpferstraße 17

    Bautzen

  • Investigational site, Bahnhofstraße 18

    Berlin

  • Investigational site, Blankenburger Chaussee 86

    Berlin

  • Investigational site, Bundesallee 104-105

    Berlin

  • Investigational site, Ehrenfelsstraße 47

    Berlin

  • Investigational site, Etkar-Andre-Straße 8

    Berlin

  • Investigational site, Hohenzollerndamm 47a

    Berlin

  • Investigational site, Innsbrucker Straße 58

    Berlin

  • Investigational site, Klosterstraße 34

    Berlin

  • Investigational site, Kurfürstendamm 42

    Berlin

  • Investigational site, Mohrenstraße 6

    Berlin

  • Investigational site, Myslowitzer Straße 49

    Berlin

  • Investigational site, Schönhauser Allee 118

    Berlin

  • Investigational site, Schönhauser Allee 129

    Berlin

  • Investigational site, Schönstraße 90

    Berlin

  • Investigational site, Treskowallee 99

    Berlin

  • Investigational site, Hauptstraße 88

    Bielefeld

  • Investigational site, Hauptstraße 9

    Bietigheim-Bissingen

  • Investigational site, Kasernenstraße 22-24

    Bonn

  • Investigational site, Münsterstraße 18

    Bonn

  • Investigational site, Propst-Sievert-Weg 9

    Borken

  • Investigational site, Trauerberg 27-28

    Brandenburg/Havel

  • Investigational site, Wetzlarer Straße 22

    Butzbach

  • Investigational site, Hermann-Hesse-Platz 3

    Calw

  • Investigational site, Dortmunder Straße

    Castrop-Rauxl

  • Investigational site, Hainstraße 112

    Chemnitz

  • Investigational site, Graseggerstraße 105

    Cologne

  • Investigational site, Venloer Straße 247

    Cologne

  • Investigational site, Bahnhofstraße 64

    Cottbus

  • Investigational site, Vetschauer Straße 11a

    Cottbus

  • Investigational site, Frankfurter Straße 3

    Darmstadt

  • Investigational site, Rheinstraße 44-46

    Darmstadt

  • Investigational site, Lagesche Straße 19

    Detmold

  • Investigational site, Jahnstraße 1

    Dingolfing

  • Investigational site, Karlsbader Straße 7

    Dinkelsbühl

  • Investigational site, Recklinghäuser Straße 14

    Dorsten

  • Investigational site, Rheinlanddamm 10

    Dortmund

  • Investigational site, Lukasstraße 3

    Dresden

  • Investigational site, Rehefelder Straße 12

    Dresden

  • Investigational site, Mühlhäuser Straße 94, Haus F

    Eisenach

  • Investigational site, Winkelgasse 1

    Ellefeld

  • Investigational site, Königstraße 12-14

    Elmshorn

  • Investigational site, Märkischestraße 30

    Engelskirchen

  • Investigational site, Franz-Busbach-Straße 8

    Erftstadt

  • Investigational site, Neuwerkstraße 2

    Erfurt

  • Investigational site, Ruhrallee 81

    Essen

  • Investigational site, Viktoriastraße 5

    Euskirchen

  • Investigational site, Im Prüfling 23

    Frankfurt

  • Investigational site, Hochstraße 43

    Frankfurt am Main

  • Investigational site, Pfingsweidstraße 4

    Frankfurt am Main

  • Investigational site, Stresemannallee 3

    Frankfurt am Main

  • Investigational site, Habsburgerstraße 105

    Freiburg im Breisgau

  • Investigational site, Schnetzenhauser Straße 5

    Friedrichshafen

  • Investigational site, Moststraße 19

    Fürth

  • Investigational site, Gartenstraße 29

    Gardelegen

  • Investigational site, Hauptstraße 60-64

    Garmisch-Partenkirchen

  • Investigational site, Am Markt 3

    Gehrden

  • Investigational site, In der Heide 19

    Gelsenkirchen

  • Investigational site, Von-der-Recke-Straße 14

    Gelsenkirchen

  • Investigational site, Pollinger Straße 23

    Gilching

  • Investigational site, Von-Werth-Straße 5

    Grevenbroich

  • Investigational site, Avenwedder Straße 50

    Gütersloh

  • Investigational site, Hachelweg 19

    Hachelweg 19

  • Investigational site, Fürstin-Eugenie-Straße 7

    Hachingen

  • Investigational site, Buscheystraße 15a

    Hagen

  • Investigational site, Eppendorfer Baum 35-37

    Hamburg

  • Investigational site, Eppendorfer Landstraße 42

    Hamburg

  • Investigational site, Fontenay 1d

    Hamburg

  • Investigational site, Harksheider Straße 3

    Hamburg

  • Investigational site, Schlossstrasse 44

    Hamburg

  • Investigational site, Schäferkampsallee 56-58

    Hamburg

  • Investigational site, Sudetenweg 6

    Hamm

  • Investigational site, Staufenbergstraße 31

    Heilbronn

  • Investigational site, Frankfurter Straße 100a

    Hennef (Sieg)

  • Investigational site, Am Ruschenhof 24

    Herne

  • Investigational site, Wiescherstraße 20

    Herne

  • Investigational site, Seestraße 43

    Herrsching am Ammersee

  • Investigational site, Waisenhausstraße 2

    Iserlohn

  • Investigational site, J.-Lange-straße 20

    Jerichow

  • Investigational site, Prinzenallee 10

    Jever

  • Investigational site, Hans-Sachs-Straße 1

    Karlsruhe

  • Investigational site, Am Tiefen Weg 2

    Karlstadt am Main

  • Investigational site, Opernstraße 9

    Kassel

  • Investigational site, Feldstraße 5-7

    Kiel

  • Investigational site, Moltkestraße 9

    Kitzingen

  • Investigational site, Herzog-Adolph-Straße 13

    Königstein

  • Investigational site, Schalaunische Straße 6-7

    Köthen

  • Investigational site, Dreifaltigkeitsplatz 177

    Landshut

  • Investigational site, Röntgenstraße 6-8

    Langen

  • Investigational site, Funkenburgstraße 19

    Leipzig

  • Investigational site, Johannisplatz 1

    Leipzig

  • Investigational site, Markt 3

    Leisnig

  • Investigational site, Am Gesundheitspark 11

    Leverkusen

  • Investigational site, Kronsforder Allee 19

    Lübeck

  • Investigational site, Kronsforder Allee 69

    Lübeck

  • Investigational site, Yorckstraße 1

    Ludwigshafen

  • Investigational site, Bismarckplatz 1

    Mannheim

  • Investigational site, Stiftsweg 17

    Mechernich

  • Investigational site, Am Harras 2

    München

  • Investigational site, Irisstraße 23

    München

  • Investigational site, Kaulbachstraße 61

    München

  • Investigational site, Maximilianstraße 16

    München

  • Investigational site, Schönfeldstraße 16

    München

  • Investigational site, Unterer Markt 26-27

    Neumarkt

  • Investigational site, Hofgründchen 13

    Neuwied

  • Investigational site, Am Stadtpark 2

    Nuremberg

  • Investigational site, Glogauer Straße 42

    Nuremberg

  • Investigational site, Weiltinger Straße 11

    Nuremberg

  • Investigational site, Hauptstraße 36

    Oldenburg

  • Investigational site, Neue Donnerschweer Straße 30

    Oldenburg

  • Investigational site, Ofener Straße 30

    Oldenburg

  • Investigational site, Bramscher Straße 242

    Osnabrück

  • Investigational site, Le-Mans-Wall 5

    Paderborn

  • Investigational site, Westendstraße 38

    Paderborn

  • Investigational site, Haptkanal rechts 75

    Papenburg

  • Investigational site, Neundorfer Straße 14

    Plauen

  • Investigational site, Allee nach Sanccouci 7

    Potsdam

  • Investigational site, Großbeerenstraße 301

    Potsdam

  • Investigational site, R.-Breitscheid-Straße 56

    Potsdam

  • Investigational site, Kaiserstraße 166

    Radevormwald

  • Investigational site, Neue Straße 34

    Reinsdorf

  • Investigational site, Keramikerstraße 61

    Rheinbach

  • Investigational site, St.-Petersburger-straße 18c

    Rostock

  • Investigational site, Tegernseerstraße 100

    Rottach-Weissach

  • Investigational site, Marktplatz 23

    Rottenburg

  • Investigational site, Waldhausstraße 13

    Schmalkalden

  • Investigational site, Krankenhausstraße 20

    Schwalmstadt

  • Investigational site, Virchowstraße 10c

    Singen

  • Investigational site, Wallstraße 38

    Stade

  • Investigational site, Am Wallgraben 99

    Stuttgart

  • Investigational site, Röhre 1

    Sundern

  • Investigational site, Straße des Friedens 34c

    Teuchern

  • Investigational site, Hambrocker Straße 53

    Uelzen

  • Investigational site, Andreaestraße 16/1

    Vahingen

  • Investigational site, Hochstraße 20

    Waltrop

  • Investigational site, Kletzstraße 13B

    Waren

  • Investigational site, Fischergasse 16

    Weilheim

  • Investigational site, Julius-Leber-Strasße 8

    Wesel

  • Investigational site, Westring 14

    Wesseling

  • Investigational site, Forsthausstraße 1e

    Wetzlar

  • Investigational site, Berliner Straße 8

    Wittenberg

Other trials in Germany

About this study

Official title: Mesalazine (PENTASA®) in Ulcerative Colitis: Correlation of the Information Level With Patient's Compliance in Everyday Practice

This non-interventional study examines whether the patient's level of information and the consideration of the patient's preference have a positive effect on the compliance and thus also on the therapeutic success.

Being tested
Mesalazine
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MesalazineOther

    Patient's treated with oral Mesalazine

Study groups in NCT01517607
Study groupRoleWhat they receive
MesalazineNot described
Receives: Other: Mesalazine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient compliance: Measured by patient response to a questionnaire

    Measured: Month 0 - Month 12

Secondary outcomes (6)

  1. Patient's level of information: Measured by patient response to a questionnaire

    Measured: Month 0 - Month 12

  2. Patient's preference for the oral pharmaceutical form: Measured by patient response to a questionnaire

    Measured: Month 0 - Month 12

  3. Reasons for the therapeutic decision of the physician: Measured by physician responses

    Measured: Month 0

  4. Laboratory parameters of predefined blood measurements

    Faecal calprotectin (including test used), faecal lactoferrin. Number of leukocytes, C-reactive protein, blood sedimentation rate. Haemoglobin, serum iron, serum ferritin, transferrin saturation (TSAT)

    Measured: Month 0- Month 12

  5. Ulcerative Colitis Disease Activity Index (UCDAI)

    UCDAI = Blood in stool, stool frequency, overall evaluation of the physician, endoscopic evaluation (optional)

    Measured: Month 0 - Month 12

  6. Adverse drug reactions: measured by number of patients and event severity

    Measured: Month 0 - Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

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
Cohort
Time perspective
Prospective
Enrolment
506 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01517607
Sponsor's protocol ID
000027
Acronym
MUKOSA
Status last verified
Sep 2015
First submitted
20 Jan 2012
Last updated
1 Oct 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Ulcerative Colitis, run by Ferring Pharmaceuticals at 149 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 3 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 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 149 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?

Patient compliance: Measured by patient response to a questionnaire (time frame: Month 0 - Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01517607.

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 Oct 2015.

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Mesalazine (PENTASA®) in Ulcerative Colitis | AzTrials