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

University of Louisville (UOFL)

Status and phase: Completed; Phase 4

Conditions: Gastroparesis; Gastroesophageal Reflux Disease

Treatments: Drug: Immediate-release omeprazole; Drug: Delayed-release omeprazole

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00492622

014.07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Immediate-release omeprazole release first

Experimental group

Description:

subjects receive immediate release omeprazole for 7 days then delayed release for 7 days

Treatment:

Drug: Immediate-release omeprazole

Drug: Delayed-release omeprazole

Delayed-release omeprazole first

Experimental group

Description:

subjects receive delayed release omeprazole for 7 days then immediate release for 7 days

Treatment:

Drug: Immediate-release omeprazole

Drug: Delayed-release omeprazole