Chest Pain Pilot Study - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00251901

Purpose

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.

Condition	Intervention	Phase
Chest Pain Gastroesophageal Reflux	Drug: Esomeprazole	Phase II Phase III

MedlinePlus related topics: Chest Pain GERD

Drug Information available for: Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy 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.

Further study details as provided by AstraZeneca:

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.

Estimated Enrollment:	600
Study Start Date:	May 2004

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00251901

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Nexium Medical Sciences Director, MD

AstraZeneca

More Information

Study ID Numbers:	D9914C00001
Study First Received:	November 9, 2005
Last Updated:	November 9, 2005
ClinicalTrials.gov Identifier:	NCT00251901
Health Authority:	Canada: Health Canada

Keywords provided by AstraZeneca:

Gastroesophageal reflux disease
GERD

Study placed in the following topic categories:

Deglutition Disorders
Esophageal Motility Disorders
Signs and Symptoms
Digestive System Diseases
Esophageal disorder
Gastrointestinal Diseases

Omeprazole
Pain
Esophageal Diseases
Gastroesophageal Reflux
Chest Pain

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents

Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009