Acid-Associated Heartburn Symptoms and Dose of Esomeprazole

Study Overview
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Brief Summary
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This is a multi-center, double-blind, parallel-group, randomized, proof of concept trial to investigate the relationship between dose of esomeprazole magnesium and acid-associated heartburn symptoms during 4 weeks of treatment. The safety and tolerability of esomeprazole magnesium in doses up to 40 mg BID will also be assessed.

Official Title
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A 4-week Study to Investigate the Relationship Between Resolution of Acid-Associated Heartburn Symptoms and Dose of Esomeprazole Magnesium

Conditions
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Heartburn

Intervention / Treatment
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* Drug: Esomeprazole magnesium (Nexium)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and non-lactating females, aged 18 to 75 years, inclusive, with the ability to understand English and provide written informed consent A history of heartburn for at least 6 months A history of prior positive relief of heartburn symptoms from antacids or acid suppressive therapy A positive esophageal acid perfusion test At least 3 days of 'moderate' severity heartburn over the previous 7 days No use of any acid suppression therapy (PPI, H2RA, etc.) within 14 days of randomization Exclusion Criteria: A history of gastric or esophageal surgery H. pylori positive A history of endoscopy -verified erosive esophagitis within the 16 weeks prior to randomization Currently taking higher than the standard approved proton pump inhibitor doses Historical evidence of a number of other GI, cardiovascular, pulmonary, liver, kidney, pancreatic, cerebral vascular diseases, organ transplant, or a condition requiring surgery.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Esomeprazole magnesium (Nexium)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained resolution of heartburn during the 4th week of treatment, defined as 7 consecutive days with a daily e-diary heartburn assessment of None. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relief of heartburn during the 4th week of treatment |  |  | 
| Cumulative daily sustained resolution rate through 4 weeks of treatment |  |  | 
| Time to first day of the first 7-day period of sustained resolution of heartburn |  |  | 
| Time to the first day of the first 7-day period of relief of heartburn |  |  | 
| Percentage of subject-reported heartburn-free days through 4 weeks of treatment |  |  | 
| Percentage of subject-reported heartburn-free nights through the 4 weeks of treatment |  |  | 
| Safety and tolerability: adverse events, clinical laboratory tests, vital signs, physical examination. |  |  |