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Completed

NCT Number: NCT00251901

Chest Pain Pilot Study

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.

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Key information

Conditions

Chest Pain Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Esomeprazole

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Nov 11, 2005
Registry last updated
Jan 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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