Status:
WITHDRAWN
Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs
Lead Sponsor:
Medstar Health Research Institute
Collaborating Sponsors:
AstraZeneca
Conditions:
Dyspepsia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The principal investigator hypothesizes that participants receiving NSAID drugs with dyspeptic symptoms have increased production of gastric levels of free radicals. The primary objective of the study...
Detailed Description
An extensive meta-analysis has confirmed that dyspeptic symptoms are common in individuals using non-steroidal anti-inflammatory drugs (NSAIDs) (1). Both esomeprazole 20 mg daily and esomeprazole 40 m...
Eligibility Criteria
Inclusion
- Participants who are capable of providing informed consent, ages 18 years old and older. Partipants who are taking non-steroidal anti-inflammatory drugs on a daily basis must present with at least a 1 week history of dyspeptic symptoms including epigastric or upper abdominal discomfort or pain.
Exclusion
- Participants presenting with only a complaint of heartburn will be excluded. Participants with alarm symptoms of vomiting, evidence of bleeding, inadvertent weight loss, or dysphagia will be excluded. Participants will be excluded if they have had upper endoscopy within 6 months prior to randomization. At the initial visit, participants will have a Helicobacter pylori IgG serology drawn and all participants with a positive serology will be excluded. Participants with a previous history of myocardial infarction, cerebrovascular infarction, gastric or duodenal ulcer disease, or carcinoma will be excluded. The study will not enroll participants who have received a H, K-ATPase inhibitor within the past 2 weeks. At the initial upper endoscopy, all participants with esophageal ulcer, esophageal cancer, gastric ulcer, gastric cancer, and duodenal ulcer will be excluded.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00443963
Start Date
December 1 2006
End Date
December 1 2006
Last Update
August 24 2020
Active Locations (1)
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1
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010