Chest Pain Pilot Study
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.
1 other identifier
interventional
600
6 countries
80
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2004
Shorter than P25 for phase_3
80 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 9, 2005
CompletedFirst Posted
Study publicly available on registry
November 11, 2005
CompletedJanuary 24, 2011
January 1, 2011
1.2 years
November 9, 2005
January 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Signs, symptoms or relevant investigations suggestion present symptomatic coronary heart disease.
- Patients whose pain or discomfort in the chest warrants urgent cardiac investigation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (80)
Research Site
Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Penticton, British Columbia, Canada
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Winkler, Manitoba, Canada
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Mount Pearl, Newfoundland and Labrador, Canada
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St. John's, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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Burlington, Ontario, Canada
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Etobicoke, Ontario, Canada
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Hamilton, Ontario, Canada
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North York, Ontario, Canada
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Toronto, Ontario, Canada
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Windsor, Ontario, Canada
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Charlottetown, Prince Edward Island, Canada
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Saint-Léonard, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Charlottenlund, Denmark
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Elsinore, Denmark
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Esbjerg, Denmark
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Frederiksberg, Denmark
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Frederikssund, Denmark
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Herning, Denmark
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Hillerød, Denmark
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Kolding, Denmark
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København K, Denmark
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København NV, Denmark
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Odense, Denmark
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Odense C, Denmark
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Randers, Denmark
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Vejle, Denmark
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Stuttgart, Baden-Wurttemberg, Germany
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Augsburg, Bavaria, Germany
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Hanover, Lower Saxony, Germany
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Saarbrücken, Saarland, Germany
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Dresden, Saxony, Germany
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Halle, Saxony-Anhalt, Germany
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Bad Segeberg, Schleswig-Holstein, Germany
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Berlin, State of Berlin, Germany
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Augsburg, Germany
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Bad Segeberg, Germany
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Berlin, Germany
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Chemnitz, Germany
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Dillingen, Germany
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Dresden, Germany
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Görlitz, Germany
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Hermaringen, Germany
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Leipzig, Germany
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Löbau, Germany
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Magdeburg, Germany
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Münster, Germany
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Weener, Germany
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Wolmirstedt, Germany
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Lichtenvoorde, Gelderland, Netherlands
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Deurne, North Brabant, Netherlands
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Oldebroek, Overijssel, Netherlands
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Hoogvliet, South Holland, Netherlands
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Rijswijk, South Holland, Netherlands
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Roelofarendsveen, South Holland, Netherlands
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Rotterdam, South Holland, Netherlands
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's-Hertogenbosch, Netherlands
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Beek en Donk, Netherlands
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Hoogwoud, Netherlands
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Huizen, Netherlands
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Nijverdal, Netherlands
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Spijkenisse, Netherlands
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Tilburg, Netherlands
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Bergen, Norway
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Gjøvik, Norway
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Hønefoss, Norway
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Nestun, Norway
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Oslo, Norway
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Skedsmokorset, Norway
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Åkersberga, Sweden
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Gothenburg, Sweden
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Krokom, Sweden
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Norrtälje, Sweden
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Östersund, Sweden
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Stockholm, Sweden
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Trollhättan, Sweden
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Umeå, Sweden
Related Publications (2)
Wade D, Cooper J, Derry F, Taylor J. Uro-Vaxom(R) versus placebo for the prevention of recurrent symptomatic urinary tract infections in participants with chronic neurogenic bladder dysfunction: a randomised controlled feasibility study. Trials. 2019 Apr 16;20(1):223. doi: 10.1186/s13063-019-3275-x.
PMID: 30992071DERIVEDFlook NW, Moayyedi P, Dent J, Talley NJ, Persson T, Karlson BW, Ruth M. Acid-suppressive therapy with esomeprazole for relief of unexplained chest pain in primary care: a randomized, double-blind, placebo-controlled trial. Am J Gastroenterol. 2013 Jan;108(1):56-64. doi: 10.1038/ajg.2012.369. Epub 2012 Nov 13.
PMID: 23147520DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Nexium Medical Sciences Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 9, 2005
First Posted
November 11, 2005
Study Start
May 1, 2004
Primary Completion
July 1, 2005
Study Completion
July 1, 2005
Last Updated
January 24, 2011
Record last verified: 2011-01