Nexium Dyspepsia/AST

January 21, 2011 updated by: AstraZeneca

Supportive Test for Acid-Related Symptoms (STARS II) With Esomeprazole and a Following 7-week, Double-blind, Randomized, Placebo Controlled Treatment Period in Uninvestigated Subjects With Upper Gastrointestinal Symptoms.

The aim is to evaluate if the resolution of upper abdominal symptoms (pain or burning) during an acid suppressive test trial of esomprazole given daily for 7 days predicts symptoms resolution at the end of a subsequent treatment period of 7 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1200

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

  • Austria
      • Braunau, Austria
        • Research Site
      • Graz, Austria
        • Research Site
      • Krems, Austria
        • Research Site
      • Linz, Austria
        • Research Site
      • Salzburg, Austria
        • Research Site
      • Sankt Pölten, Austria
        • Research Site
      • St. Johann, Austria
        • Research Site
      • Wien, Austria
        • Research Site
      • Wiener Neustadt, Austria
        • Research Site
      • Zell am See, Austria
        • Research Site
  • Belgium
      • Ans, Belgium
        • Research Site
      • Brussels (Uccle), Belgium
        • Research Site
      • Gozée, Belgium
        • Research Site
      • Halle, Belgium
        • Research Site
      • Kontich, Belgium
        • Research Site
      • Kortenberg, Belgium
        • Research Site
      • Kraainem, Belgium
        • Research Site
      • Linkebeek, Belgium
        • Research Site
      • Liège, Belgium
        • Research Site
      • Massemen, Belgium
        • Research Site
      • Moerkerke, Belgium
        • Research Site
      • Natoye, Belgium
        • Research Site
      • Oud-Heverlee, Belgium
        • Research Site
      • Saint-Médard, Belgium
        • Research Site
      • Soignies, Belgium
        • Research Site
      • Waremme, Belgium
        • Research Site
      • Wezembeek- Oppem, Belgium
        • Research Site
      • Wingene, Belgium
        • Research Site
      • Zoersel, Belgium
        • Research Site
      • Zolder, Belgium
        • Research Site
      • Zonhoven, Belgium
        • Research Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Research Site
      • Edmonton, Alberta, Canada
        • Research Site
    • British Columbia
      • Kelowna, British Columbia, Canada
        • Research Site
      • Penticton, British Columbia, Canada
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Research Site
    • Newfoundland and Labrador
      • Bay Roberts, Newfoundland and Labrador, Canada
        • Research Site
      • St. John's, Newfoundland and Labrador, Canada
        • Research Site
    • Nova Scotia
      • Elmsdale, Nova Scotia, Canada
        • Research Site
      • Halifax, Nova Scotia, Canada
        • Research Site
    • Ontario
      • Ajax, Ontario, Canada
        • Research Site
      • Brampton, Ontario, Canada
        • Research Site
      • Burlington, Ontario, Canada
        • Research Site
      • Dorchester, Ontario, Canada
        • Research Site
      • Hamilton, Ontario, Canada
        • Research Site
      • Kanata, Ontario, Canada
        • Research Site
      • Kitchener, Ontario, Canada
        • Research Site
      • London, Ontario, Canada
        • Research Site
      • Markham, Ontario, Canada
        • Research Site
      • Mississauga, Ontario, Canada
        • Research Site
      • Niagara Falls, Ontario, Canada
        • Research Site
      • North York, Ontario, Canada
        • Research Site
      • Orleans, Ontario, Canada
        • Research Site
      • Oshawa, Ontario, Canada
        • Research Site
      • Ottawa, Ontario, Canada
        • Research Site
      • Richmond Hill, Ontario, Canada
        • Research Site
      • Sainte Gedeon-de-Beauce, Ontario, Canada
        • Research Site
      • Scarborough, Ontario, Canada
        • Research Site
      • St Catherines, Ontario, Canada
        • Research Site
      • Stirling, Ontario, Canada
        • Research Site
      • Thunder Bay, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
      • Tottenham, Ontario, Canada
        • Research Site
      • Whitby, Ontario, Canada
        • Research Site
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada
        • Research Site
      • Parkdale, Prince Edward Island, Canada
        • Research Site
    • Quebec
      • Charlesbourg, Quebec, Canada
        • Research Site
      • Granby, Quebec, Canada
        • Research Site
      • Saint-Leonard, Quebec, Canada
        • Research Site
      • Sainte-Foy, Quebec, Canada
        • Research Site
  • Finland
      • Espoo, Finland
        • Research Site
      • Helsinki, Finland
        • Research Site
      • Kouvola, Finland
        • Research Site
      • Lempäälä, Finland
        • Research Site
      • Pirkkala, Finland
        • Research Site
      • Pori, Finland
        • Research Site
      • Sahalahti, Finland
        • Research Site
      • Tampere, Finland
        • Research Site
      • Vääksy, Finland
        • Research Site
  • France
      • Angers, France
        • Research Site
      • Dambach La Ville, France
        • Research Site
      • Dijon, France
        • Research Site
      • La Seyne Sur Mer, France
        • Research Site
      • Laxou, France
        • Research Site
      • Louviers, France
        • Research Site
      • MONT DE MARSAN Cedex, France
        • Research Site
      • NANCY Cedex, France
        • Research Site
      • Saint-ouen, France
        • Research Site
      • Vieux Conde, France
        • Research Site
  • Germany
      • Lochham, Germany
        • Research Site
      • München, Germany
        • Research Site
      • Rödental, Germany
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Budaörs, Hungary
        • Research Site
      • Esztergom, Hungary
        • Research Site
      • Hatvan, Hungary
        • Research Site
      • Nagykanizsa, Hungary
        • Research Site
      • Siófok, Hungary
        • Research Site
      • Tát, Hungary
        • Research Site
      • Zalaegerszeg, Hungary
        • Research Site
  • Mexico
      • Culiacán, Mexico
        • Research Site
      • Guadalajara, Mexico
        • Research Site
      • León, Mexico
        • Research Site
      • México, Mexico
        • Research Site
      • Torreón, Mexico
        • Research Site
    • D.F
      • Mexico, D.F, Mexico
        • Research Site
  • Norway
      • Bekkestua, Norway
        • Research Site
      • Bergen, Norway
        • Research Site
      • Hønefoss, Norway
        • Research Site
      • Lier, Norway
        • Research Site
      • Lysaker, Norway
        • Research Site
      • Moss, Norway
        • Research Site
      • Oslo, Norway
        • Research Site
      • Paradis, Norway
        • Research Site
      • Rykkinn, Norway
        • Research Site
      • Rådal, Norway
        • Research Site
      • Sandefjord, Norway
        • Research Site
      • Skien, Norway
        • Research Site
      • Søgne, Norway
        • Research Site
      • Tvedestrand, Norway
        • Research Site
      • Østerås, Norway
        • Research Site
  • South Africa
      • Bloemfontein, South Africa
        • Research Site
      • Boksburg, South Africa
        • Research Site
      • Cape Town, South Africa
        • Research Site
      • Durban, South Africa
        • Research Site
      • Halfway House, South Africa
        • Research Site
      • Lyttelton Manor, South Africa
        • Research Site
      • Pretoria, South Africa
        • Research Site
    • Gauteng
      • Lenasia, Gauteng, South Africa
        • Research Site
  • Sweden
      • Fritsla, Sweden
        • Research Site
      • Göteborg, Sweden
        • Research Site
      • Halmstad, Sweden
        • Research Site
      • Höganäs, Sweden
        • Research Site
      • Ingelstad, Sweden
        • Research Site
      • Jönköping, Sweden
        • Research Site
      • Kalmar, Sweden
        • Research Site
      • Kilafors, Sweden
        • Research Site
      • Kristinehamn, Sweden
        • Research Site
      • Kungsör, Sweden
        • Research Site
      • Motala, Sweden
        • Research Site
      • Munkedal, Sweden
        • Research Site
      • Norrtälje, Sweden
        • Research Site
      • Nässjö, Sweden
        • Research Site
      • Rättvik, Sweden
        • Research Site
      • Staffanstorp, Sweden
        • Research Site
      • Sundsbruk, Sweden
        • Research Site
      • Trollhättan, Sweden
        • Research Site
      • Uddevalla, Sweden
        • Research Site
      • Upplands Väsby, Sweden
        • Research Site
      • Vällingby, Sweden
        • Research Site
      • Västerås, Sweden
        • Research Site
      • Växjö, Sweden
        • Research Site
      • Ängelholm, Sweden
        • Research Site
  • Switzerland
      • Aarau, Switzerland
        • Research Site
      • Brittnau, Switzerland
        • Research Site
      • Küttigen, Switzerland
        • Research Site
      • Schaffhausen, Switzerland
        • Research Site
      • Zürich, Switzerland
        • Research Site
    • Bern
      • Schönbühl-Urtenen, Bern, Switzerland
        • Research Site
    • Zürich
      • Egg bei Zürich, Zürich, Switzerland
        • Research Site
      • Winterthur, Zürich, Switzerland
        • Research Site
  • United Kingdom
      • Audley, United Kingdom
        • Research Site
      • Blackburn, United Kingdom
        • Research Site
      • Blackpool, United Kingdom
        • Research Site
      • Chesterfield, United Kingdom
        • Research Site
      • Coventry, United Kingdom
        • Research Site
      • Enfield, United Kingdom
        • Research Site
      • Glasgow, United Kingdom
        • Research Site
      • Hadleigh, United Kingdom
        • Research Site
      • Harrow, United Kingdom
        • Research Site
      • Irvine, United Kingdom
        • Research Site
      • Mansfield, United Kingdom
        • Research Site
      • Nottingham, United Kingdom
        • Research Site
      • Sheffield, United Kingdom
        • Research Site
      • Shrewsbury, United Kingdom
        • Research Site
      • Slough, United Kingdom
        • Research Site
      • Titchfield, United Kingdom
        • Research Site
      • Tonbridge, United Kingdom
        • Research Site
      • Tunbridge Wells, United Kingdom
        • Research Site
      • Watford, United Kingdom
        • Research Site
    • Cambridgeshire
      • Ely, Cambridgeshire, United Kingdom
        • Research Site
    • Surrey
      • Woking, Surrey, United Kingdom
        • 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

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least 3 months of symptoms of pain or burning centered in the upper abdomen prior to enrollment.
  • Helicobacter pylori test performed at enrollment must be negative (Helicobacter pylori is a bacterial infection of the stomach).

Exclusion Criteria:

  • Patients with symptoms of other gastrointestinal diseases, such as Gastroesophageal Reflux Disease (GERD), Irritable Bowel Syndrome (IBS) or Inflammatory Bowel Disease (IBD).
  • Helicobacter pylori eradication treatment during the last 12 months prior to enrollment.

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
The primary outcome is whether the patient is a responder or not after 8 weeks treatment.
The primary efficacy outcome is based on symptom score recorded daily during the study in a patient diary.
The patient will judge their symptoms of pain or burning centered in the upper abdomen on a four-graded scale (none, mild, moderate or severe).

Secondary Outcome Measures

Outcome Measure
The secondary efficacy outcomes are whether the patient is a responder or not after 4 weeks,
The average symptom score and the percentage of symptom-free days during the 7-week treatment period,
Presence/absence of specific GI symptoms after 4 and 8 weeks of 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

December 1, 2002

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

November 9, 2005

First Submitted That Met QC Criteria

November 9, 2005

First Posted (Estimate)

November 11, 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SD-NED-0022
  • D9610C00022

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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