Clinical trial NCT00492622: Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Gastroparesis
Official title: Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Patients With Heartburn Associated With Gastroparesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastroparesis
Gastroesophageal Reflux Disease
Keywords: Gastroparesis
Gastroesophageal reflux disease
heartburn
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: Bausch Health Americas, Inc.
First posted: 2007-06-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Time to Maximal Omeprazole Concentration (Tmax)
timeFrame: 10, 20, 30, 45, 60, 90, 120, 150, 180, 210, 240 and 300 min after the study drug was ingested on day 7 of treatment
measure: Maximal Concentration of Omerazole
timeFrame: 10, 20, 30, 45, 60, 90, 120, 150, 180, 210, 240 and 300 min after the study drug was ingested on day 7 of treatment
measure: Area Under the Curve for Omeprazole Plasma Concentration
timeFrame: 0 to 5 hrs after the study drug was ingested on treatment day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Digestive Health Center, University of Louisville Hospital
state: Kentucky
Study officials:
affiliation: University of Louisville
name: John M Wo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wo JM, Eversmann J, Mann S. Pharmacokinetic profile of immediate-release omeprazole in patients with gastro-oesophageal reflux associated with gastroparesis. Aliment Pharmacol Ther. 2010 Feb 15;31(4):516-22. doi: 10.1111/j.1365-2036.2009.04203.x. Epub 2009 Nov 19.