Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Patients With Heartburn Associated With Gastroparesis
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.
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.
Status: Completed (Phase 4). Started on June 1st, 2007.
Enrollment: 15 subjects
Study Type: Interventional
Study Design:
- Allocation: Randomized
- Endpoint Classification: Pharmacodynamics Study
- Intervention Model: Crossover Assignment
- Masking: Open Label
- Primary Purpose: Treatment
Conditions:
Interventions:
- Drug: Immediate-release omeprazole
- Drug: Delayed-release omeprazole
Eligibility
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.
- Gender
Both
- Mininum Age
18 Years
- Maximum Age
80 Years
- Healthy Volunteers
No
Resources
Source: University of Louisville
Authority: United States: Institutional Review Board
Locations
-
Digestive Health Center, University of Louisville Hospital
Louisville
Kentucky
40202
United States
Officials
John M Wo, MD (Principal Investigator, University of Louisville)
Sponsors
University of Louisville (Lead Sponsor)
Santarus (Collaborator)
References
None.
Links
None.
- Date Verified
- August 1st, 2011
- First Received
- September 21st, 2011
- Last Changed
- September 21st, 2011
Information obtained from ClinicalTrials.gov on September 21, 2011. Link to the current ClinicalTrials.gov record.
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