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

Gastroesophageal Reflux Disease Clinical Trial

Official title:

Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Patients With Heartburn Associated With Gastroparesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00492622
• Other study ID #: 014.07
• Status: Completed
• Phase: Phase 4
• First received: June 26, 2007
• Last updated: September 21, 2011
• Start date: June 2007
• Est. completion date: December 2008

Study information

• Verified date: August 2011
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

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.

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Gastroparesis

Intervention

Drug:
• Immediate-release omeprazole
Immediate-release omeprazole 40 mg qam for 7 days
• Delayed-release omeprazole
Delayed-release omeprazole 40 mg qam for 7 days

Locations

Country	Name	City	State
United States	Digestive Health Center, University of Louisville Hospital	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Louisville	Valeant Pharmaceuticals International, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 200 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		7 days	Yes