Esomeprazole (NEXIUM) vs. Surgery

Last updated: August 7, 2012
Sponsor: AstraZeneca
Overall Status: Completed

Phase

3

Condition

Gastroesophageal Reflux Disease (Gerd)

Esophageal Disorders

Heartburn (Pediatric)

Treatment

N/A

Clinical Study ID

NCT00251927
D9612C00003
SH-NEG-0003
  • Ages 18-70
  • All Genders

Study Summary

The study investigates the efficacy of long-term treatment of esomeprazole compared to anti-reflux surgery in the control of gastroesophageal reflux disease by assessing time to treatment failure.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects considered suitable for surgical treatment and long-term management ofesomeprazole.

  • History of chronic reflux esophagitis or symptomatic GERD

Exclusion

Exclusion Criteria:

  • History of esophageal, gastric, or duodenal surgery predicted to influence negativelyon subsequent treatment within the study.

  • Contraindication to the study drug.

  • Pregnancy, lactating or of child-bearing potential.

Study Design

Total Participants: 626
Study Start date:
October 01, 2001
Estimated Completion Date:
April 30, 2009

Connect with a study center

  • Research Site

    Linz,
    Austria

    Site Not Available

  • Research Site

    Wien,
    Austria

    Site Not Available

  • Research Site

    Zell am See,
    Austria

    Site Not Available

  • Research Site

    Brussels,
    Belgium

    Site Not Available

  • Research Site

    Brussels (Anderlecht),
    Belgium

    Site Not Available

  • Research Site

    Brussels (Woluwé-St-Lambert),
    Belgium

    Site Not Available

  • Research Site

    Brussels (Woluwé-St-Lambert),
    Belgium

    Site Not Available

  • Research Site

    Gent,
    Belgium

    Site Not Available

  • Research Site

    Haine-Saint-Paul,
    Belgium

    Site Not Available

  • Research Site

    Leuven,
    Belgium

    Site Not Available

  • Research Site

    Liège,
    Belgium

    Site Not Available

  • Research Site

    Liège,
    Belgium

    Site Not Available

  • Research Site

    Rimavska Sobota,
    Belgium

    Site Not Available

  • Research Site

    Glostrup,
    Denmark

    Site Not Available

  • Research Site

    Herning,
    Denmark

    Site Not Available

  • Research Site

    Hillerød,
    Denmark

    Site Not Available

  • Research Site

    Hillerød,
    Denmark

    Site Not Available

  • Research Site

    Hvidovre,
    Denmark

    Site Not Available

  • Research Site

    Kolding,
    Denmark

    Site Not Available

  • Research Site

    Odense C,
    Denmark

    Site Not Available

  • Research Site

    Viborg,
    Denmark

    Site Not Available

  • Research Site

    Ã…rhus C,
    Denmark

    Site Not Available

  • Research Site

    Århus C,
    Denmark

    Site Not Available

  • Research Site

    Kuopio,
    Finland

    Site Not Available

  • Research Site

    Tampere,
    Finland

    Site Not Available

  • Research Site

    Bordeaux,
    France

    Site Not Available

  • Research Site

    Creteil,
    France

    Site Not Available

  • Research Site

    GRENOBLE Cedex 09,
    France

    Site Not Available

  • Research Site

    NIMES Cedex 4,
    France

    Site Not Available

  • Research Site

    Nantes,
    France

    Site Not Available

  • Research Site

    Nice,
    France

    Site Not Available

  • Research Site

    Rouen,
    France

    Site Not Available

  • Research Site

    01307 Dresden,
    Germany

    Site Not Available

  • Research Site

    Dresden, 01307
    Germany

    Site Not Available

  • Research Site

    Frankfurt,
    Germany

    Site Not Available

  • Research Site

    Hamburg,
    Germany

    Site Not Available

  • Research Site

    Heidelberg,
    Germany

    Site Not Available

  • Research Site

    Herne,
    Germany

    Site Not Available

  • Research Site

    Köln,
    Germany

    Site Not Available

  • Research Site

    Köln,
    Germany

    Site Not Available

  • Research Site

    München,
    Germany

    Site Not Available

  • Research Site

    München,
    Germany

    Site Not Available

  • Research Site

    Tübingen,
    Germany

    Site Not Available

  • Research Site

    Tübingen,
    Germany

    Site Not Available

  • Research Site

    Wiesbaden,
    Germany

    Site Not Available

  • Research Site

    Würzburg,
    Germany

    Site Not Available

  • Research Site

    Würzburg,
    Germany

    Site Not Available

  • Research Site

    Reykjavik,
    Iceland

    Site Not Available

  • Research Site

    Brescia,
    Italy

    Site Not Available

  • Research Site

    Firenze,
    Italy

    Site Not Available

  • Research Site

    Modena,
    Italy

    Site Not Available

  • Research Site

    Monfalcone,
    Italy

    Site Not Available

  • Research Site

    Padova,
    Italy

    Site Not Available

  • Research Site

    Perugia,
    Italy

    Site Not Available

  • Research Site

    Pisa,
    Italy

    Site Not Available

  • Research Site

    Rozzano,
    Italy

    Site Not Available

  • Research Site

    San Donato Milanese,
    Italy

    Site Not Available

  • Research Site

    Torino,
    Italy

    Site Not Available

  • Research Site

    Utrecht,
    Netherlands

    Site Not Available

  • Research Site

    Bergen,
    Norway

    Site Not Available

  • Research Site

    Bodø,
    Norway

    Site Not Available

  • Research Site

    Bodø,
    Norway

    Site Not Available

  • Research Site

    Kristiansand S,
    Norway

    Site Not Available

  • Research Site

    Oslo,
    Norway

    Site Not Available

  • Research Site

    Tromsø,
    Norway

    Site Not Available

  • Research Site

    Tromsø,
    Norway

    Site Not Available

  • Research Site

    Trondheim,
    Norway

    Site Not Available

  • Research Site

    Göteborg,
    Sweden

    Site Not Available

  • Research Site

    Göteborg,
    Sweden

    Site Not Available

  • Research Site

    Lund,
    Sweden

    Site Not Available

  • Research Site

    Salford,
    United Kingdom

    Site Not Available

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