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

This study has been completed.
Sponsor:
Collaborator:
Santarus
Information provided by (Responsible Party):
University of Louisville
ClinicalTrials.gov Identifier:
NCT00492622
First received: June 26, 2007
Last updated: September 21, 2011
Last verified: August 2011
History of Changes

June 26, 2007
September 21, 2011
June 2007
December 2008   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00492622 on ClinicalTrials.gov Archive Site
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Not Provided
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Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Gastroparesis
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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Gastroparesis
  • Gastroesophageal Reflux Disease
  • 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
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00492622
014.07
No
University of Louisville
University of Louisville
Santarus
Principal Investigator: John M Wo, MD University of Louisville
University of Louisville
August 2011

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