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

June 29, 2017 updated by: University of Louisville

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate-release omeprazole release first
subjects receive immediate release omeprazole for 7 days then delayed release for 7 days
Drug: Immediate-release omeprazole
Immediate-release omeprazole 40 mg qam for 7 days
Drug: Delayed-release omeprazole
Delayed-release omeprazole 40 mg qam for 7 days
Experimental: Delayed-release omeprazole first
subjects receive delayed release omeprazole for 7 days then immediate release for 7 days
Drug: Immediate-release omeprazole
Immediate-release omeprazole 40 mg qam for 7 days
Drug: Delayed-release omeprazole
Delayed-release omeprazole 40 mg qam for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Maximal Omeprazole Concentration (Tmax)
Time Frame: 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
Time to max concentration for Immediate release vs. Delayed release omeprazole
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
Maximal Concentration of Omerazole
Time Frame: 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
Maximal concentration of immediate-release vs. delayed-release omeprazole
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
Area Under the Curve for Omeprazole Plasma Concentration
Time Frame: 0 to 5 hrs after the study drug was ingested on treatment day 7
The area under the curve for omeprazole concentration-time curve for immediate release and delayed release omeprazole.
0 to 5 hrs after the study drug was ingested on treatment day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Collaborators

Bausch Health Americas, Inc.

Investigators

  • Principal Investigator: John M Wo, MD, University of Louisville

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

June 26, 2007

First Submitted That Met QC Criteria

June 26, 2007

First Posted (Estimate)

June 27, 2007

Study Record Updates

Last Update Posted (Actual)

July 28, 2017

Last Update Submitted That Met QC Criteria

June 29, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 014.07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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