Chest Pain Pilot Study
Phase 3
Completed
- Conditions
- Chest PainGastroesophageal Reflux
- Registration Number
- NCT00251901
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which esomeprazole alleviates acid-related chest pain in GERD patients?
How does esomeprazole 40 mg bid compare to other PPIs in managing symptoms of gastroesophageal reflux disease?
Which biomarkers correlate with symptom response to PPI therapy in patients with non-erosive reflux disease?
What are the long-term adverse event profiles of high-dose PPIs like esomeprazole 40 mg bid in GERD treatment?
How does esomeprazole's efficacy in NCT00251901 compare to newer therapies like potassium-competitive acid blockers?
Trial Locations
- Locations (1)
Research Site
🇸🇪Östersund, Sweden
Research Site🇸🇪Östersund, Sweden