Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Gastroparesis

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Louisville
• Collaborators: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Treatments: Omeprazole

Criteria

Inclusion Criteria:

• Symptoms of heartburn >2 days per week off antireflux therapy, defined by "a burning feeling rising from the stomach or lower chest up towards the neck"

• Symptoms of gastroparesis >1 month in duration, defined by nausea, vomiting, bloating, dyspepsia, early satiety, or effortless regurgitation.

• Prior abnormal 4-hour gastric emptying scan within the past 3 years

Exclusion Criteria:

• History of esophageal or gastric surgery

• Severe gastroparesis with any of the following: vomiting with dehydration requiring IV hydration, hospitalization, weight loss >10 % pre-illness weight, requiring feeding jejunostomy tubes

• Presence of gastric electrical stimulator

• Symptoms of retching with vomiting more than 2 days per week

• Diagnosis of diabetes

• Disorders of small bowel motility (such as pseudo-obstruction or dumping syndrome)

• Disorders of small bowel absorption

• Diagnosis of gastric outlet, small bowel or colon mechanical obstruction

• Diagnosis of acid hypersecretory syndrome

• Disorders affecting proton pump inhibitor metabolism (such as liver failure)

• Known allergy or side effects to proton pump inhibitor

• Non-ambulatory patients: bed-ridden, nursing home resident, etc.

• Pregnancy