Chest Pain Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00251901
Recruitment Status : Completed
First Posted : November 11, 2005
Last Update Posted : January 24, 2011
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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.

Condition or disease Intervention/treatment Phase
Chest Pain Gastroesophageal Reflux Drug: Esomeprazole Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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.
Study Start Date : May 2004
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Relief of pain or discomfort in the chest during the last week of the 4-week treatment course.
  2. 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 :
  1. Symptom response during the first week is based on diary cards, days 3-7.
  2. The investigator's overall assessment of pain or discomfort in the chest during the first and fourth week.
  3. Scores from the PRO instruments measuring pain, HRQL, anxiety and depression, health status, reflux related symptoms and overall treatment evaluation.
  4. Adverse events, clinical laboratory variables and vital signs.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00251901

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Sponsors and Collaborators
Study Director: AstraZeneca Nexium Medical Sciences Director, MD AstraZeneca

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00251901     History of Changes
Other Study ID Numbers: D9914C00001
First Posted: November 11, 2005    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
Gastroesophageal reflux disease

Additional relevant MeSH terms:
Gastroesophageal Reflux
Chest Pain
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action