A Multicenter, Randomized, Double-Blind Parallel-Group, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg Once Daily to Placebo qd for the Resolution of Upper Abdominal Pain in Patients With Symptomatic Gastroesophageal Reflux Disease (sGERD)

Study Overview
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Brief Summary
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This study compares 4 weeks of treatment with Esomeprazole 20 mg once daily to Placebo in the treatment of Upper Abdominal Pain in patients with Symptomatic Gastroesophageal Reflux Disease (sGERD)

Official Title
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A Multicenter, Randomized, Double-Blind Parallel-Group, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg Once Daily to Placebo qd for the Resolution of Upper Abdominal Pain in Patients With Symptomatic Gastroesophageal Reflux Disease (sGERD)

Conditions
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Symptomatic Gastroesophageal Reflux Disease (sGERD)

Intervention / Treatment
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* Drug: Esomeprazole
* Drug: Matching placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of episodes of heartburn and upper abdominal pain for 6 months or longer. Episodes of heartburn 2 or more days during the 7 days prior to the screening visit. Moderate or severe upper abdominal pain on at least 3 out of the 7 consecutive days of the run-in period. A normal endoscopy within 14 days of Visit 1 of between Run-in and randomization. Exclusion Criteria: Subjects with pain likely to be due to irritable bowel syndrome (IBS) History of esophageal, gastric or duodenal surgery, except for closure of an ulcer. History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis. Further diseases / conditions, as listed in the protocol.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>20mg once daily | Drug: Esomeprazole<br>* 20mg Oral Once Daily<br>* Other names: Nexium;|
| Placebo Comparator: 2<br>Oral once daily | Drug: Matching placebo<br>* Oral Once Daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate a difference between esomeprazole 20 mg once daily and placebo qd in the resolution and relief of upper abdominal pain after 4 weeks of treatment in patients with sGERD |  | Daily diary cards completed by the patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate a difference between esomeprazole 20 mg once daily and placebo qd in the resolution and relief of upper abdominal pain after 1, 2, and 4 weeks of treatment in patients with sGERD |  | Daily diary cards completed by the patient | 
| To demonstrate a difference in percentage of days with, days to resolution of, and severity of upper abdominal pain through 4 weeks of treatment between esomeprazole 20 mg once daily and placebo qd in patients with sGERD |  | Percentage of days without upper abdominal pain over the 4-week treatment period | 
| To assess the safety and tolerability of esomeprazole 20 mg qd through 4 weeks of treatment. |  | Mean severity of the patient's upper abdominal pain over the last 4 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Symptomatic Gastroesophageal Reflux Disease (sGERD), Nexium, Esomeprazole