Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Gastroparesis
Information source: University of Louisville
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroparesis; Gastroesophageal Reflux Disease
Intervention: Immediate-release omeprazole (Drug); Delayed-release omeprazole (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Louisville Official(s) and/or principal investigator(s):
John M Wo, MD, Principal Investigator, Affiliation: University of Louisville
Overall contact:
Jennifer Eversmann, RN, Phone: 502-852-3365, Email: jennifer.eversmann@louisville.edu
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.
Clinical Details
Official title: Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Patients With Heartburn Associated With Gastroparesis
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacodynamics Study
Primary outcome: 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
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Jennifer Eversmann, RN, Phone: 502-852-3365, Email: jennifer.eversmann@louisville.edu
Digestive Health Center, University of Louisville Hospital, Louisville, Kentucky 40202, United States; Recruiting
Jennifer Eversmann, RN, Phone: 502-852-3365, Email: jennifer.eversmann@louisville.edu
John M Wo, MD, Principal Investigator
Additional Information
Starting date: June 2007
Ending date: December 2007
Last updated: September 6, 2007
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