Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Gastroparesis
|Gastroparesis Gastroesophageal Reflux Disease||Drug: Immediate-release omeprazole Drug: Delayed-release omeprazole||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Patients With Heartburn Associated With Gastroparesis|
- Pharmacokinetics of immediate-release omeprazole vs. delayed release omeprazole when administered 60 min prior to a standardized fatty breakfast: 1) time to max concentration, 2) max concentration, 3) area-under-curve [ Time Frame: 7 days ]
|Study Start Date:||June 2007|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Drug: Immediate-release omeprazole
Hypothesis: Immediate-release omeprazole suspension may have a more rapid pharmacokinetic profile and greater overall drug absorption in gastroparesis. This will result in shorter time to maximal drug concentration, greater maximal concentration, and greater total area under the curve of the concentration vs. time plot.
Primary Objective: To compare the pharmacokinetics of omeprazole between immediate-release suspension and delayed-release capsules in patients with heartburn associated with gastroparesis.
Study design: randomized, open-labeled, crossover treatment for 7 days with 10-14 days washout. Pharmacokinetic studies will be performed after 7 days on study drug.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00492622
|United States, Kentucky|
|Digestive Health Center, University of Louisville Hospital|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||John M Wo, MD||University of Louisville|