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Chest Pain Pilot Study

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00251901
First received: November 9, 2005
Last updated: January 21, 2011
Last verified: January 2011
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Chest Pain GERD
U.S. FDA Resources

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
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Show 79 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Nexium Medical Sciences Director, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00251901     History of Changes
Other Study ID Numbers: D9914C00001
Study First Received: November 9, 2005
Last Updated: January 21, 2011
Health Authority: Canada: Health Canada

Keywords provided by AstraZeneca:
Gastroesophageal reflux disease
GERD

Additional relevant MeSH terms:
Chest Pain
Gastroesophageal Reflux
Pain
Signs and Symptoms
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013