Efficacy of Esomeprazole in Patients With Frequent Heartburn

Study Overview
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Brief Summary
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This study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment of frequent heartburn

Official Title
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A Phase III Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of 14 Day Treatment With Esomeprazole 20 mg Once Daily in Subjects With Frequent Heartburn

Conditions
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Heartburn

Intervention / Treatment
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* Drug: Esomeprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and non-pregnant ,non-lactating females 18 years or older Experience heartburn at least 2 days a week Having heartburn that has responded to heartburn medication Must discontinue any current heartburn medications Exclusion Criteria: Having a history of erosive esophagitis verified by endoscopy Having a history of GERD which was diagnosed by a physician Inability to take study medication or complete the study and all study procedures Subjects that have required more than one 14-day course of PPI treatment within the past 4 months

Ages Eligible for Study
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Minimum Age: 18 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Esomeprazole 20 mg<br> | Drug: Esomeprazole<br>* Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate, capsule, oral dose<br>|
| Placebo Comparator: Placebo<br> | Drug: Esomeprazole<br>* Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate, capsule, oral dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment |  | From randomisation to day 14 | 
| Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment |  | From randomization to day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period | Randomized treatment period is considered as both weeks 1 and 2 between V3 and V4. | From randomisation to day 14 | 
| Comparison of Number of Subjects With 0, 1, 2, 3 or 4 Days With no Heartburn Over Days 1 to 4 Between Esomeprazole 20 mg and Placebo | The first 4 consecutive days subjects were on randomized treatment, between V3 and V4. | From randomisation to the day 14 | 
| Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment | There were three separate 7 day time periods during the treatment period; The first week (days 1-7), the second week (days 8-14), and the last 7 consecutive days (last day subject reported and the prior 6). For a given subject, the second week and last 7 consecutive days are the same if the subject has recorded measurements for the entire 14 day treatment period. However, for subjects reporting anything less than 14 days the two will not be identical. For all three 7 day time periods, days when a subject did not call in (i.e., missing values) were imputed as a day with heartburn. | From randomisation to day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heartburn