NCT00251901CompletedPhase 3
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.
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 600
- Locations
- 76
- Primary Endpoint
- Relief of pain or discomfort in the chest during the last week of the 4-week treatment course.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- 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.
Outcomes
Primary Outcomes
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 Outcomes
- 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.
Investigators
Study Sites (76)
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