Chest Pain, Gastroesophageal Reflux
Conditions
Keywords
Gastroesophageal reflux disease, GERD
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.
Interventions
DRUGEsomeprazole
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Canada, Denmark, Germany, Netherlands, Norway, Sweden
Outcome results
None listed