Chest Pain Pilot Study

Chest Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00251901
• Other study ID #: D9914C00001
• Status: Completed
• Phase: Phase 3
• First received: November 9, 2005
• Last updated: January 21, 2011
• Start date: May 2004
• Est. completion date: July 2005

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chest Pain
• Gastroesophageal Reflux

Intervention

Drug:
• Esomeprazole

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Canada,  Denmark,  Germany,  Netherlands,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relief of pain or discomfort in the chest during the last week of the 4-week treatment course.
Primary	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	Symptom response during the first week is based on diary cards, days 3-7.
Secondary	The investigator's overall assessment of pain or discomfort in the chest during the first and fourth week.
Secondary	Scores from the PRO instruments measuring pain, HRQL, anxiety and depression, health status, reflux related symptoms and overall treatment evaluation.
Secondary	Adverse events, clinical laboratory variables and vital signs.