Healia Clinical Trials Information Database

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.

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.

Status: Completed (Phase 4). Started on June 1st, 2007.

Enrollment: 15 subjects

Study Type: Interventional

Study Design:

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

Conditions:

Interventions:

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

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

Gender

Both

Mininum Age

18 Years

Maximum Age

80 Years

Healthy Volunteers

No


Resources

Source: University of Louisville

Authority: United States: Institutional Review Board

Locations

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

Officials

  • John M Wo, MD (Principal Investigator, University of Louisville)

Sponsors

  • University of Louisville (Lead Sponsor)

  • Santarus (Collaborator)

References

None.

Links

None.


Date Verified
August 1st, 2011
First Received
September 21st, 2011
Last Changed
September 21st, 2011

Information obtained from ClinicalTrials.gov on September 21, 2011. Link to the current ClinicalTrials.gov record.


All data in the Healia Clinical Trials Information Database and content displayed by the Healia Clinical Trials Search Engine are licensed from the National Institutes of Health (National Library of Medicine), which collects and maintains the data.

The Healia Clinical Trials Search Engine searches the data set at clinicaltrials.gov, providing up-to-date information about current clinical trials. In the Healia Clinical Trials Database you can find information on new experimental drugs, medical devices, and other types of treatments for all types of diseases. Each clinical trial description includes information about the phase of the trial (phase I, phase II, or phase III), the trial’s methods, such as whether it is a randomized, placebo controlled, double blind study, and the status of the trial including whether or not the trial is currently enrolling new participants.


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