Status:
COMPLETED
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)
Lead Sponsor:
AstraZeneca
Conditions:
Symptomatic Gastroesophageal Reflux Disease (sGERD)
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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)
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2004
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00626535
Start Date
March 1 2003
End Date
February 1 2004
Last Update
March 12 2009
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