Clinical trial NCT00251901: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chest Pain
Gastroesophageal Reflux
Keywords: Gastroesophageal reflux disease
GERD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-11
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Relief of pain or discomfort in the chest during the last week of the 4-week treatment course.
measure: 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:
measure: Symptom response during the first week is based on diary cards, days 3-7.
measure: The investigator's overall assessment of pain or discomfort in the chest during the first and fourth week.
measure: Scores from the PRO instruments measuring pain, HRQL, anxiety and depression, health status, reflux related symptoms and overall treatment evaluation.
measure: Adverse events, clinical laboratory variables and vital signs.
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Penticton
country: Canada
facility: Research Site
state: British Columbia
city: Winkler
country: Canada
facility: Research Site
state: Manitoba
city: Mount Pearl
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Burlington
country: Canada
facility: Research Site
state: Ontario
city: Etobicoke
country: Canada
facility: Research Site
state: Ontario
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: North York
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Windsor
country: Canada
facility: Research Site
state: Ontario
city: Charlottetown
country: Canada
facility: Research Site
state: Prince Edward Island
city: Saint-Leonard
country: Canada
facility: Research Site
state: Quebec
city: Saskatoon
country: Canada
facility: Research Site
state: Saskatchewan
city: Charlottenlund
country: Denmark
facility: Research Site
city: Esbjerg
country: Denmark
facility: Research Site
city: Frederiksberg
country: Denmark
facility: Research Site
city: Frederikssund
country: Denmark
facility: Research Site
city: Helsingør
country: Denmark
facility: Research Site
city: Herning
country: Denmark
facility: Research Site
city: Hillerød
country: Denmark
facility: Research Site
city: Kolding
country: Denmark
facility: Research Site
city: København K
country: Denmark
facility: Research Site
city: København NV
country: Denmark
facility: Research Site
city: Odense C
country: Denmark
facility: Research Site
city: Odense
country: Denmark
facility: Research Site
city: Randers
country: Denmark
facility: Research Site
city: Vejle
country: Denmark
facility: Research Site
city: Stuttgart
country: Germany
facility: Research Site
state: Baden-Württemberg
city: Augsburg
country: Germany
facility: Research Site
state: Bayern
city: Hannover
country: Germany
facility: Research Site
state: Niedersachsen
city: Saarbrücken
country: Germany
facility: Research Site
state: Saarland
city: Halle
country: Germany
facility: Research Site
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: Research Site
state: Sachsen
city: Bad Segeberg
country: Germany
facility: Research Site
state: Schleswig-Holstein
city: Augsburg
country: Germany
facility: Research Site
city: Bad Segeberg
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Chemnitz
country: Germany
facility: Research Site
city: Dillingen
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Görlitz
country: Germany
facility: Research Site
city: Hermaringen
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Löbau
country: Germany
facility: Research Site
city: Magdeburg
country: Germany
facility: Research Site
city: Münster
country: Germany
facility: Research Site
city: Weener
country: Germany
facility: Research Site
city: Wolmirstedt
country: Germany
facility: Research Site
city: Lichtenvoorde
country: Netherlands
facility: Research Site
state: Gelderland
city: Deurne
country: Netherlands
facility: Research Site
state: Noord-Brabant
city: Oldebroek
country: Netherlands
facility: Research Site
state: Overijssel
city: Hoogvliet
country: Netherlands
facility: Research Site
state: Zuid-Holland
city: Rijswijk
country: Netherlands
facility: Research Site
state: Zuid-Holland
city: Roelofarendsveen
country: Netherlands
facility: Research Site
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Research Site
state: Zuid-Holland
city: Beek En Donk
country: Netherlands
facility: Research Site
city: Den Bosch
country: Netherlands
facility: Research Site
city: Hoogwoud
country: Netherlands
facility: Research Site
city: Huizen
country: Netherlands
facility: Research Site
city: Nijverdal
country: Netherlands
facility: Research Site
city: Spijkenisse
country: Netherlands
facility: Research Site
city: Tilburg
country: Netherlands
facility: Research Site
city: Bergen
country: Norway
facility: Research Site
city: Gjøvik
country: Norway
facility: Research Site
city: Hønefoss
country: Norway
facility: Research Site
city: Nestun
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Skedsmokorset
country: Norway
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Krokom
country: Sweden
facility: Research Site
city: Norrtälje
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Trollhättan
country: Sweden
facility: Research Site
city: Umeå
country: Sweden
facility: Research Site
city: Åkersberga
country: Sweden
facility: Research Site
city: Östersund
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Nexium Medical Sciences Director, MD
role: STUDY_DIRECTOR
References:
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.
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.