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 Gastroe

• Status: Completed
• Trial end date: 2004-02-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Esomeprazole

Criteria

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.