Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Gastroparesis - Full Text View

Sponsor:	University of Louisville
Collaborator:	Santarus
Information provided by (Responsible Party):	University of Louisville
ClinicalTrials.gov Identifier:	NCT00492622

Purpose

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.

Condition	Intervention	Phase
Gastroparesis Gastroesophageal Reflux Disease	Drug: Immediate-release omeprazole Drug: Delayed-release omeprazole	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Patients With Heartburn Associated With Gastroparesis

Resource links provided by NLM:

MedlinePlus related topics: GERD Heartburn

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by University of Louisville:

Primary Outcome Measures:

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 [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	15
Study Start Date:	June 2007
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Immediate-release omeprazole 40 mg qam for 7 days

Delayed-release omeprazole 40 mg qam for 7 days

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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492622

Locations

United States, Kentucky
Digestive Health Center, University of Louisville Hospital
Louisville, Kentucky, United States, 40202

Sponsors and Collaborators

University of Louisville

Santarus

Investigators

Principal Investigator:

John M Wo, MD

University of Louisville

More Information

Publications:

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. Epub 2009 Nov 19.

Responsible Party:	University of Louisville
ClinicalTrials.gov Identifier:	NCT00492622 History of Changes
Other Study ID Numbers:	014.07
Study First Received:	June 26, 2007
Last Updated:	September 21, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Louisville:

Gastroparesis
Gastroesophageal reflux disease
heartburn

Additional relevant MeSH terms:

Gastroesophageal Reflux
Gastroparesis
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Paralysis

Neurologic Manifestations
Signs and Symptoms
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012