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)

Official Title: “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)”

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)

Intervention(s) in this Clinical Trial

• Drug: Esomeprazole
  • 20mg Oral Once Daily
• Drug: Matching placebo
  • Oral Once Daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 20mg once daily
• Placebo Comparator: 2
  • Oral once daily

Primary Measures

• 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 Measures

• 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.
    

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

Paula Fernstrom Study Director Nexium Global Product Director, AstraZeneca  

Information obtained from ClinicalTrials.gov on February 02, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00626535

Study ID Number: D9619C00001

ClinicalTrials.gov Identifier: NCT00626535

Health Authority: United States: Food and Drug Administration