Gastroenterology
Volume 135, Issue 5 , Pages 1510-1516, November 2008

Oral Budesonide for Maintenance Treatment of Collagenous Colitis: A Randomized, Double-Blind, Placebo-Controlled Trial

  • Stephan Miehlke

      Affiliations

    • Medical Department I, Technical University Hospital, Dresden, Germany
    • Corresponding Author InformationAddress requests for reprints to: Prof Stephan Miehlke, Medical Department I, Technical University Hospital, Fetscherstr. 74, 01307 Dresden, Germany
    • ,
  • Ahmed Madisch

      Affiliations

    • Medical Department I, Technical University Hospital, Dresden, Germany
    • ,
  • Birgit Bethke

      Affiliations

    • Institute of Pathology, Klinikum Bayreuth, Germany
    • ,
  • Andrea Morgner

      Affiliations

    • Medical Department I, Technical University Hospital, Dresden, Germany
    • ,
  • Eberhard Kuhlisch

      Affiliations

    • Institute for Medical Statistics & Biometry, Technical University Hospital, Dresden, Germany
    • ,
  • Christine Henker

      Affiliations

    • Medical Department I, Technical University Hospital, Dresden, Germany
    • ,
  • Gerfried Vogel

      Affiliations

    • Private Practice, Neumarkt, Germany
    • ,
  • Matthias Andersen

      Affiliations

    • Internal Medicine, St.-Vincenz Hospital, Datteln, Germany
    • ,
  • Eberhard Meier

      Affiliations

    • Private Practice, Amberg, Germany
    • ,
  • Gustavo Baretton

      Affiliations

    • Institute for Pathology, Technical University Hospital, Dresden, Germany
    • ,
  • Manfred Stolte

      Affiliations

    • Institute of Pathology, Klinikum Bayreuth, Germany

Received 3 June 2008; accepted 31 July 2008. published online 08 August 2008.

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 The corresponding author had full access to all of the data and takes full responsibility for the veracity of the data and analysis.

 All authors contributed to interpretation of the study findings and in the writing of the manuscript. Medical writing support was provided by Steve Winter, from Wolters Kluwer Health (Chester, UK), with funding from AstraZeneca.

 The authors are indebted to the following investigators for their participation in this study: W. Barina, Würzburg; N. Bockelmann, Gedern; F. Emke, Osnabrück; G. Franke, Dinkelsbühl; S. Gernert, Ochsenfurt; B. Grosse, Willich; J. Grossmann, Mönchengladbach; C. Haferland, Görlitz; T. Henn, Bad Kissingen; W. Hennig, Bayreuth; T. Höhler, Recklinghausen; I. Hofmann, Stadtsteinach; J. Kärner, Trier; J. Keymling, Wedemark; R. Kölble, Düsseldorf; C. Krödel, Bad Brückenau; G. Lösken, Melle; C. Lücke, Beilstein; A. Lütke, Koblenz; S. Mielck, Plön; T. Montag, Eutin; H. Peβler, Ahorntal; J. Philipzik, Aldingen; F. Richter, Sigmaringen; J. Rintelmann, Bad Nenndorf; A. Rodenbostel, Baden-Baden; S. Roder, Talheim; J. Scholle, Menden; K. Schultze, Bremerhaven; W. Simon, Würzburg; T. Sokolowski, München; G. Walker, Pirmasens; W. Weber, Berlin; B. Wigginghaus, Osnabrück; and M. Zimmermann, Konradsreuth.

 The authors disclose the following: Potential investigator conflicts of interest, where relevant, were not disclosed to study participants.

 The statistical analysis of the entire data sets pertaining to efficacy (specifically primary and major secondary efficacy end points) and safety was independently conducted by a biostatistician (EK) who is not employed by the study sponsor.

 Supported by AstraZeneca.

 SM has received honoraria from AstraZeneca for consultancies and oral presentations, and research grant support from AstraZeneca. AMa has received honoraria from AstraZeneca for consultancies, oral presentations, and research grant support from AstraZeneca. AMo has received honoraria from AstraZeneca for consultancies and oral presentations. MS has received honoraria as an invited speaker for AstraZeneca. BB, EK, CH, GV, MA and GB have no conflicts of interest to declare.

PII: S0016-5085(08)01457-1

doi:10.1053/j.gastro.2008.07.081

Gastroenterology
Volume 135, Issue 5 , Pages 1510-1516, November 2008

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