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

Tracking Information

First Received Date ^ICMJE

June 26, 2007

Last Updated Date

February 13, 2009

Start Date ^ICMJE

June 2007

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00492622 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacodynamics Study

Condition ^ICMJE

Gastroparesis
Gastroesophageal Reflux Disease

Intervention ^ICMJE

Drug: Immediate-release omeprazole
Drug: Delayed-release omeprazole

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

December 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00492622

Responsible Party

John M. Wo, M.D., University of Louisville

Study ID Numbers ^ICMJE

014.07

Study Sponsor ^ICMJE

University of Louisville

Collaborators ^ICMJE

Santarus

Investigators ^ICMJE

Principal Investigator:

John M Wo, MD

University of Louisville

Information Provided By

University of Louisville

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP