Back to resultsChest Pain Pilot Study
Primary Purpose
Chest Pain, Gastroesophageal Reflux
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Esomeprazole
Sponsored by
About this trial
This is an interventional treatment trial for Chest Pain focused on measuring Gastroesophageal reflux disease, GERD
Eligibility Criteria
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.
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Outcomes
Primary Outcome Measures
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00251901
Brief Title
Chest Pain Pilot Study
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain, Gastroesophageal Reflux
Keywords
Gastroesophageal reflux disease, GERD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
600 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Primary Outcome Measure Information:
Title
Relief of pain or discomfort in the chest during the last week of the 4-week treatment course.
Title
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 Measure Information:
Title
Symptom response during the first week is based on diary cards, days 3-7.
Title
The investigator's overall assessment of pain or discomfort in the chest during the first and fourth week.
Title
Scores from the PRO instruments measuring pain, HRQL, anxiety and depression, health status, reflux related symptoms and overall treatment evaluation.
Title
Adverse events, clinical laboratory variables and vital signs.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Nexium Medical Sciences Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Research Site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Research Site
City
Penticton
State/Province
British Columbia
Country
Canada
Facility Name
Research Site
City
Winkler
State/Province
Manitoba
Country
Canada
Facility Name
Research Site
City
Mount Pearl
State/Province
Newfoundland and Labrador
Country
Canada
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Research Site
City
St. John's
State/Province
Newfoundland and Labrador
Country
Canada
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Halifax
State/Province
Nova Scotia
Country
Canada
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Burlington
State/Province
Ontario
Country
Canada
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City
Etobicoke
State/Province
Ontario
Country
Canada
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City
Hamilton
State/Province
Ontario
Country
Canada
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North York
State/Province
Ontario
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Canada
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Toronto
State/Province
Ontario
Country
Canada
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Windsor
State/Province
Ontario
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Canada
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Charlottetown
State/Province
Prince Edward Island
Country
Canada
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City
Saint-Leonard
State/Province
Quebec
Country
Canada
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City
Saskatoon
State/Province
Saskatchewan
Country
Canada
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Research Site
City
Charlottenlund
Country
Denmark
Facility Name
Research Site
City
Esbjerg
Country
Denmark
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City
Frederiksberg
Country
Denmark
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Research Site
City
Frederikssund
Country
Denmark
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Research Site
City
Helsingør
Country
Denmark
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City
Herning
Country
Denmark
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Research Site
City
Hillerød
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Denmark
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City
Kolding
Country
Denmark
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Research Site
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København K
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Denmark
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København NV
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Denmark
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Odense C
Country
Denmark
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City
Odense
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Denmark
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City
Randers
Country
Denmark
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Research Site
City
Vejle
Country
Denmark
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Research Site
City
Stuttgart
State/Province
Baden-Württemberg
Country
Germany
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City
Augsburg
State/Province
Bayern
Country
Germany
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City
Hannover
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Niedersachsen
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Germany
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Saarbrücken
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Saarland
Country
Germany
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Halle
State/Province
Sachsen-Anhalt
Country
Germany
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Dresden
State/Province
Sachsen
Country
Germany
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City
Bad Segeberg
State/Province
Schleswig-Holstein
Country
Germany
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Augsburg
Country
Germany
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City
Bad Segeberg
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Germany
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Berlin
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Germany
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Chemnitz
Country
Germany
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City
Dillingen
Country
Germany
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Dresden
Country
Germany
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City
Görlitz
Country
Germany
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Hermaringen
Country
Germany
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Leipzig
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Germany
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Löbau
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Germany
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Magdeburg
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Germany
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Münster
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Germany
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Weener
Country
Germany
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Wolmirstedt
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Germany
Facility Name
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City
Lichtenvoorde
State/Province
Gelderland
Country
Netherlands
Facility Name
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City
Deurne
State/Province
Noord-Brabant
Country
Netherlands
Facility Name
Research Site
City
Oldebroek
State/Province
Overijssel
Country
Netherlands
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Research Site
City
Hoogvliet
State/Province
Zuid-Holland
Country
Netherlands
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Research Site
City
Rijswijk
State/Province
Zuid-Holland
Country
Netherlands
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Roelofarendsveen
State/Province
Zuid-Holland
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Netherlands
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City
Rotterdam
State/Province
Zuid-Holland
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Netherlands
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City
Beek En Donk
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Netherlands
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Den Bosch
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Netherlands
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Hoogwoud
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Netherlands
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Huizen
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Netherlands
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Nijverdal
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Netherlands
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City
Spijkenisse
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Netherlands
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Tilburg
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Netherlands
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Bergen
Country
Norway
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City
Gjøvik
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Norway
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Hønefoss
Country
Norway
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City
Nestun
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Norway
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Oslo
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Norway
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City
Skedsmokorset
Country
Norway
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City
Göteborg
Country
Sweden
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City
Krokom
Country
Sweden
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Norrtälje
Country
Sweden
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Stockholm
Country
Sweden
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Trollhättan
Country
Sweden
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Umeå
Country
Sweden
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City
Åkersberga
Country
Sweden
Facility Name
Research Site
City
Östersund
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
30992071
Citation
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.
Results Reference
derived
PubMed Identifier
23147520
Citation
Flook 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.
Results Reference
derived
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Chest Pain Pilot Study
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