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)

AstraZeneca500 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

500

Conditions

Symptomatic Gastroesophageal Reflux Disease (sGERD)

Interventions

EsomeprazoleDRUG

20mg Oral Once Daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: Daily diary cards completed by the patient

Secondary Outcomes

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

Time frame: 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

Time frame: 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.

Time frame: Mean severity of the patient's upper abdominal pain over the last 4 weeks.