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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014