Overview

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