Chest Pain Pilot Study

January 21, 2011 updated by: AstraZeneca

A Randomized Double-Blind Placebo-Controlled Multi-Centre Pilot Study to Assess Symptom Response in Subjects With Pain or Discomfort in the Chest Receiving Oral Treatment With Esomeprazole 40 mg Bid for 4 Weeks.

The purpose of this study is to compare the efficacy of Nexium® with placebo in relief of acid related pain or discomfort in the chest.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

600

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Research Site
      • Edmonton, Alberta, Canada
        • Research Site
    • British Columbia
      • Penticton, British Columbia, Canada
        • Research Site
    • Manitoba
      • Winkler, Manitoba, Canada
        • Research Site
    • Newfoundland and Labrador
      • Mount Pearl, Newfoundland and Labrador, Canada
        • Research Site
      • St. John's, Newfoundland and Labrador, Canada
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Research Site
    • Ontario
      • Burlington, Ontario, Canada
        • Research Site
      • Etobicoke, Ontario, Canada
        • Research Site
      • Hamilton, Ontario, Canada
        • Research Site
      • North York, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
      • Windsor, Ontario, Canada
        • Research Site
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada
        • Research Site
    • Quebec
      • Saint-Leonard, Quebec, Canada
        • Research Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • Research Site
  • Denmark
      • Charlottenlund, Denmark
        • Research Site
      • Esbjerg, Denmark
        • Research Site
      • Frederiksberg, Denmark
        • Research Site
      • Frederikssund, Denmark
        • Research Site
      • Helsingør, Denmark
        • Research Site
      • Herning, Denmark
        • Research Site
      • Hillerød, Denmark
        • Research Site
      • Kolding, Denmark
        • Research Site
      • København K, Denmark
        • Research Site
      • København NV, Denmark
        • Research Site
      • Odense, Denmark
        • Research Site
      • Odense C, Denmark
        • Research Site
      • Randers, Denmark
        • Research Site
      • Vejle, Denmark
        • Research Site
  • Germany
      • Augsburg, Germany
        • Research Site
      • Bad Segeberg, Germany
        • Research Site
      • Berlin, Germany
        • Research Site
      • Chemnitz, Germany
        • Research Site
      • Dillingen, Germany
        • Research Site
      • Dresden, Germany
        • Research Site
      • Görlitz, Germany
        • Research Site
      • Hermaringen, Germany
        • Research Site
      • Leipzig, Germany
        • Research Site
      • Löbau, Germany
        • Research Site
      • Magdeburg, Germany
        • Research Site
      • Münster, Germany
        • Research Site
      • Weener, Germany
        • Research Site
      • Wolmirstedt, Germany
        • Research Site
    • Baden-Württemberg
      • Stuttgart, Baden-Württemberg, Germany
        • Research Site
    • Bayern
      • Augsburg, Bayern, Germany
        • Research Site
    • Niedersachsen
      • Hannover, Niedersachsen, Germany
        • Research Site
    • Saarland
      • Saarbrücken, Saarland, Germany
        • Research Site
    • Sachsen
      • Dresden, Sachsen, Germany
        • Research Site
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany
        • Research Site
    • Schleswig-Holstein
      • Bad Segeberg, Schleswig-Holstein, Germany
        • Research Site
  • Netherlands
      • Beek En Donk, Netherlands
        • Research Site
      • Den Bosch, Netherlands
        • Research Site
      • Hoogwoud, Netherlands
        • Research Site
      • Huizen, Netherlands
        • Research Site
      • Nijverdal, Netherlands
        • Research Site
      • Spijkenisse, Netherlands
        • Research Site
      • Tilburg, Netherlands
        • Research Site
    • Gelderland
      • Lichtenvoorde, Gelderland, Netherlands
        • Research Site
    • Noord-Brabant
      • Deurne, Noord-Brabant, Netherlands
        • Research Site
    • Overijssel
      • Oldebroek, Overijssel, Netherlands
        • Research Site
    • Zuid-Holland
      • Hoogvliet, Zuid-Holland, Netherlands
        • Research Site
      • Rijswijk, Zuid-Holland, Netherlands
        • Research Site
      • Roelofarendsveen, Zuid-Holland, Netherlands
        • Research Site
      • Rotterdam, Zuid-Holland, Netherlands
        • Research Site
  • Norway
      • Bergen, Norway
        • Research Site
      • Gjøvik, Norway
        • Research Site
      • Hønefoss, Norway
        • Research Site
      • Nestun, Norway
        • Research Site
      • Oslo, Norway
        • Research Site
      • Skedsmokorset, Norway
        • Research Site
  • Sweden
      • Göteborg, Sweden
        • Research Site
      • Krokom, Sweden
        • Research Site
      • Norrtälje, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site
      • Trollhättan, Sweden
        • Research Site
      • Umeå, Sweden
        • Research Site
      • Åkersberga, Sweden
        • Research Site
      • Östersund, Sweden
        • 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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pain or discomfort in the chest without any identifiable cause and severe enough for the patient to seek primary medical or similar care.
  • History of pain or discomfort in the chest for at least the last two weeks prior to enrollment.

Exclusion Criteria:

  • Signs, symptoms or relevant investigations suggestion present symptomatic coronary heart disease.
  • Patients whose pain or discomfort in the chest warrants urgent cardiac investigation.

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
Relief of pain or discomfort in the chest during the last week of the 4-week treatment course.
Relief of pain or discomfort in the chest is defined as no more than one day with minimal symptoms according to the patients assessment

Secondary Outcome Measures

Outcome Measure
Symptom response during the first week is based on diary cards, days 3-7.
The investigator's overall assessment of pain or discomfort in the chest during the first and fourth week.
Scores from the PRO instruments measuring pain, HRQL, anxiety and depression, health status, reflux related symptoms and overall treatment evaluation.
Adverse events, clinical laboratory variables and vital signs.

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

May 1, 2004

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

July 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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9914C00001

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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