Conditions: Gastroparesis Gastroesophageal Reflux Disease
Keywords: Gastroparesis Gastroesophageal reflux disease heartburn
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 12
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the blood drug levels of two prescribed medications, immediate-release omeprazole 40 mg powder and delayed-release omeprazole 40 mg capsule to determine which drug is better absorbed in patients with a slow stomach emptying (gastroparesis). Delayed-release omeprazole has a protective coating to prevent the drug omeprazole from being neutralized by stomach acid. Immediate-release omeprazole has sodium bicarbonate (antacid) which neutralizes the stomach acid, eliminating the need for a protective coating. Immediate-release omeprazole suspension may have a more rapid pharmacokinetic profile and greater overall drug absorption in gastroparesis.

Detailed description:
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.

Arms:
arm 1: subjects receive immediate release omeprazole for 7 days then delayed release for 7 days arm 2: subjects receive delayed release omeprazole for 7 days then immediate release for 7 days

Interventions: intervention 1: Immediate-release omeprazole intervention 2: Delayed-release omeprazole
Intervention descriptions: intervention 1: Immediate-release omeprazole 40 mg qam for 7 days intervention 2: Delayed-release omeprazole 40 mg qam for 7 days

Protocol document: