Status:
COMPLETED
Open, Randomized, Two Way Crossover 40mg, Orally and Intravenously
Lead Sponsor:
AstraZeneca
Conditions:
GERD
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This study looks at the effect on basal and pentagastrin-stimulated acid output of 40 mg Esomeprazole (Nexium) administered orally and intravenously as a 15-minute infusion to people with symptoms of ...
Eligibility Criteria
Inclusion
- Heartburn on at least 2 days of the past 7 days prior to screening, with or without a history of EE or a documented diagnosis of GERD within 6 months prior to screening, with or without a history of EE.
- Body mass index (BMI) of ≥18.5 and ≤35 kg/m2. \[BMI will be calculated using the following formula: weight (kg)/height (m)2.\]
- Able to communicate with the investigator and to understand and comply with the requirements of the study.
Exclusion
- History of esophageal, gastric, or duodenal surgery, except for simple closure of an ulcer.
- History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
- Any significant "alarm symptoms", within the past 6 months, such as, unintentional weight loss, gastrointestinal bleeding, jaundice or any other sign indicating serious or malignant disease.
- Abnormal lab test results, as indicated in the protocol.
- Other diseases, as indicated in the protocol.
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2002
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00635414
Start Date
August 1 2002
End Date
October 1 2002
Last Update
January 25 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.