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)

Phase 3

Completed

• Conditions: Symptomatic Gastroesophageal Reflux Disease (sGERD)
• Interventions: Drug: Esomeprazole; Drug: Matching placebo

• Registration Number: NCT00626535
• Lead Sponsor: AstraZeneca

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2003-03
• Primary Completion: 2004-02
• Study Completion: 2004-02
• Study First Submitted: 2008-02-21
• Study First Submitted QC: 2008-02-21
• Study First Posted: 2008-02-29
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-11
• Last Update Posted: 2009-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Esomeprazole	20mg once daily
2	Matching placebo	Oral once daily

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.