Esomeprazole for Prevention of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs

January 20, 2011 updated by: AstraZeneca

Efficacy of Esomeprazole 40 mg Once Daily Versus Placebo or Esomeprazole 20 mg Once Daily Versus Placebo in Prevention of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs Including COX-2 Selective NSAIDs

This study was a multicentre, double-blind, randomised, placebo-controlled parallel group study consisting of 4 visits over a period of 6 months. The primary variable was to assess the efficacy of esomeprazole 40 mg orally qd (E40) or esomeprazole 20 mg orally qd (E20) versus placebo orally qd after 6 months of treatment for the prevention of relapse of upper GI symptoms associated with NSAID use, including COX-2 selective NSAIDs, in patients receiving daily NSAID therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

334

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Alleur, Belgium
        • Research Site
      • Ans, Belgium
        • Research Site
      • Beernem, Belgium
        • Research Site
      • Betekom, Belgium
        • Research Site
      • Bottelaere, Belgium
        • Research Site
      • Braine-L 'Alleud, Belgium
        • Research Site
      • Buizingen, Belgium
        • Research Site
      • Duffel, Belgium
        • Research Site
      • Durnal, Belgium
        • Research Site
      • Erembodegem, Belgium
        • Research Site
      • Genk, Belgium
        • Research Site
      • Gent, Belgium
        • Research Site
      • Herentals, Belgium
        • Research Site
      • Lambermont, Belgium
        • Research Site
      • Leut, Belgium
        • Research Site
      • Linkebeek, Belgium
        • Research Site
      • Liège, Belgium
        • Research Site
      • Maasmechelen, Belgium
        • Research Site
      • Massemen, Belgium
        • Research Site
      • Merelbeke, Belgium
        • Research Site
      • Natoye, Belgium
        • Research Site
      • Nivelles, Belgium
        • Research Site
      • Oud-Heverlee, Belgium
        • Research Site
      • Seraing, Belgium
        • Research Site
      • Soignies, Belgium
        • Research Site
      • Vorst (Brussels), Belgium
        • Research Site
      • Waremme, Belgium
        • Research Site
      • Zoersel, Belgium
        • Research Site
      • Zolder, Belgium
        • Research Site
  • France
      • Albens, France
        • Research Site
      • Angers, France
        • Research Site
      • Dambach La Ville, France
        • Research Site
      • Dommartin-les-touls, France
        • Research Site
      • Fontaine Les Dijon, France
        • Research Site
      • Gemenos, France
        • Research Site
      • Geste, France
        • Research Site
      • Husseren-wesserling, France
        • Research Site
      • La Regrip, France
        • Research Site
      • Le Pian Medoc, France
        • Research Site
      • Lille, France
        • Research Site
      • Lyon, France
        • Research Site
      • MONT DE MARSAN Cedex, France
        • Research Site
      • Maromme, France
        • Research Site
      • Montingy Les Metz, France
        • Research Site
      • Paris Cedex 10, France
        • Research Site
      • Saint-ouen, France
        • Research Site
      • Strasbourg, France
        • Research Site
      • Tarare, France
        • Research Site
  • Germany
      • Berlin, Germany
        • Research Site
      • Bernau, Germany
        • Research Site
      • Bochum, Germany
        • Research Site
      • Dresden, Germany
        • Research Site
      • Dresden-Test, Germany
        • Research Site
      • Erfurt, Germany
        • Research Site
      • Erlangen, Germany
        • Research Site
      • Genthin, Germany
        • Research Site
      • Herne, Germany
        • Research Site
      • Kelkheim, Germany
        • Research Site
      • Köln, Germany
        • Research Site
      • Künzing, Germany
        • Research Site
      • Lienen, Germany
        • Research Site
      • Lüdenscheid, Germany
        • Research Site
      • München, Germany
        • Research Site
      • Münster, Germany
        • Research Site
      • Paderborn, Germany
        • Research Site
      • Passau, Germany
        • Research Site
      • Potsdam, Germany
        • Research Site
      • Ratingen, Germany
        • Research Site
      • Regensburg, Germany
        • Research Site
      • Ribnitz-Damgarten, Germany
        • Research Site
      • Saarbrücken, Germany
        • Research Site
      • Salzgitter, Germany
        • Research Site
      • Wangen, Germany
        • Research Site
      • Wiesbaden, Germany
        • Research Site
      • Wolmirstedt, Germany
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Békéscsaba, Hungary
        • Research Site
      • Dunaújváros, Hungary
        • Research Site
      • Szentes, Hungary
        • Research Site
      • Szombathely, Hungary
        • Research Site
      • Veszprém, Hungary
        • Research Site
      • Vác, Hungary
        • Research Site
  • Spain
      • Barcelona, Spain
        • Research Site
      • Getafe, Spain
        • Research Site
      • Guadalajara, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Mérida, Spain
        • Research Site
      • Palma de Mallorca, Spain
        • Research Site
      • San Sebastián(Guipuzcoa), Spain
        • Research Site
      • Sevilla, Spain
        • Research Site
      • Torrelavega, Spain
        • Research Site
      • Valencia, Spain
        • Research Site
      • Viladecans, Spain
        • Research Site
      • Zaragoza, Spain
        • Research Site
  • United States
    • Arizona
      • Tucson, Arizona, United States
        • Research Site
    • California
      • Anaheim, California, United States
        • Research Site
      • Orange, California, United States
        • Research Site
      • San Francisco, California, United States
        • Research Site
    • Florida
      • Bradenton, Florida, United States
        • Research Site
      • Clearwater, Florida, United States
        • Research Site
      • Ft. Lauderdale, Florida, United States
        • Research Site
      • Jacksonville, Florida, United States
        • Research Site
      • South Miami, Florida, United States
        • Research Site
      • West Palm Beach, Florida, United States
        • Research Site
      • Zephyr Hills, Florida, United States
        • Research Site
    • Georgia
      • Conyers, Georgia, United States
        • Research Site
    • Indiana
      • Newburgh, Indiana, United States
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States
        • Research Site
    • North Carolina
      • Winston-Salem, North Carolina, United States
        • Research Site
    • Oklahoma
      • Tulsa, Oklahoma, United States
        • Research Site
    • Pennsylvania
      • Tipton, Pennsylvania, United States
        • Research Site
    • Virginia
      • Norfolk, Virginia, United States
        • Research Site
      • Virginia Beach, Virginia, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed informed consent.
  • Completed the SH-NEN-0001 study with relief of upper GI symptom. Relief is defined as "last 7 days with a diary assessment of None or Minimal, but allowing up to 2 days to be rated as Mild during the 7-day period".
  • A clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid arthritis) that requires continuous daily NSAID treatment for at least 6 months. Daily NSAID treatment is defined as taking the prescribed dose for at least 5 of 7 days in any given week and can include COX-2 selective NSAIDs, multiple NSAIDs, and high-dose NSAIDs.
  • Daily NSAID treatment dose and type: (Must have been stable for at least 9 weeks prior to inclusion and; Are expected to remain stable for the duration of the study. and; Must be administered orally. If more than one type of NSAID treatment is used, at least one type must be administered orally).
  • Hp negative on Histology performed at baseline endoscopy in the study SHNEN- 0001.

Exclusion Criteria:

  • Discontinuation from study SH-NEN-0001
  • Pain, discomfort or burning in the upper abdomen precipitated by exercise or relieved by defecation.
  • Pain, discomfort or burning in the upper abdomen not associated with the use of NSAIDs, including COX-2 selective NSAIDs.
  • Pregnancy or lactation. Women of childbearing potential must maintain effective contraception during the study period as judged by the investigator.
  • Need for continuous concomitant therapy with: (Anticoagulants; Corticosteroids at doses higher than explained under inclusion criterion)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To assess the efficacy of esomeprazole 40 mg orally q.d. versus placebo orally q.d.
and 20 mg q.d. versus placebo orally q.d. through 6 months of treatment for the
prevention of relapse of upper GI symptom associated with NSAID use in patients
receiving daily NSAID therapy.

Secondary Outcome Measures

Outcome Measure
To assess the safety and tolerability of esomeprazole 40 mg orally q.d. versus placebo orally q.d. and 20 mg orally q.d. versus placebo orally q.d. when administered for 6 months to patients receiving daily NSAID therapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Primary Completion (Actual)

February 1, 2003

Study Completion (Actual)

February 1, 2003

Study Registration Dates

First Submitted

October 18, 2005

First Submitted That Met QC Criteria

October 18, 2005

First Posted (Estimate)

October 19, 2005

Study Record Updates

Last Update Posted (Estimate)

January 21, 2011

Last Update Submitted That Met QC Criteria

January 20, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9617C00002
  • SH-NEN-0002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe