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

January 21, 2011 updated by: AstraZeneca

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

This study is a randomised, double-blind, parallel-group and placebo controlled study comparing the efficacy of esomeprazole 40 mg orally qd vs. placebo and esomeprazole 20 mg orally qd vs. placebo when given to patients on continuous use of NSAIDs, including COX-2 selective NSAIDs, for a period of 4 weeks in treatment of relief of upper GI symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

808

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
      • Brussels (Ixelles), Belgium
        • Research Site
      • Brussels (Jette), Belgium
        • Research Site
      • Brussels (Uccle), Belgium
        • Research Site
      • Buizingen, Belgium
        • Research Site
      • Duffel, Belgium
        • Research Site
      • Durnal, Belgium
        • Research Site
      • Erembodegem, Belgium
        • Research Site
      • Forest, Belgium
        • Research Site
      • Genk, Belgium
        • Research Site
      • Gent, Belgium
        • Research Site
      • Halle, 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
      • Uccle, 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, 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
      • 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
      • Stockach, 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:

  • 18 years of age, or older.
  • Capable of completing the diary card.
  • Ability to complete the HRQL questionnaires.
  • A clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid arthritis) that requires continuous daily NSAID treatment for at least 7 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 aspirin (>325 mg/day).
  • Daily NSAID treatment dose and type: (Must have been stable for at least 4 weeks prior to baseline endoscopy and; Are expected to remain stable for the duration of the study. and; Must be administered orally for the duration of the study. If more than one type of NSAID treatment is used, at least one type must be given orally).

Exclusion Criteria:

  • Current, or history of, gastric or duodenal ulcer
  • Current, or history of, esophageal, gastric or duodenal surgery.
  • History of GERD, not associated with NSAID use.
  • 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, as judged by the investigator.
  • Endoscopic Barrett's esophagus(>3 cm) or significant dysplastic changes in the esophagus

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 versus placebo through 4 weeks of treatment of upper GI symptoms associated with nonsteroidal anti-inflammation

Secondary Outcome Measures

Outcome Measure
- To assess the safety & tolerability of esomeprazole versus placebo when administered for up to 4 weeks to patients receiving daily NSAID therapy
- To assess the impact of treatment

Collaborators and Investigators

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

Sponsor

AstraZeneca

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

January 1, 2001

Primary Completion (Actual)

August 1, 2002

Study Completion (Actual)

August 1, 2002

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 24, 2011

Last Update Submitted That Met QC Criteria

January 21, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9617C00001
  • SH-NEN-0001

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.

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