Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00492622
Recruitment Status : Completed
First Posted : June 27, 2007
Results First Posted : July 28, 2017
Last Update Posted : July 28, 2017
Sponsor:
Collaborator:
Bausch Health Americas, Inc.
Information provided by (Responsible Party):
University of Louisville

Tracking Information
First Submitted Date  ICMJE June 26, 2007
First Posted Date  ICMJE June 27, 2007
Results First Submitted Date  ICMJE April 6, 2017
Results First Posted Date  ICMJE July 28, 2017
Last Update Posted Date July 28, 2017
Study Start Date  ICMJE June 2007
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2017)
  • 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
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 26, 2007)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Gastroparesis
  • Gastroesophageal Reflux Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Immediate-release omeprazole release first
    subjects receive immediate release omeprazole for 7 days then delayed release for 7 days
    Interventions:
    • Drug: Immediate-release omeprazole
    • Drug: Delayed-release omeprazole
  • Experimental: Delayed-release omeprazole first
    subjects receive delayed release omeprazole for 7 days then immediate release for 7 days
    Interventions:
    • Drug: Immediate-release omeprazole
    • Drug: Delayed-release omeprazole
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. doi: 10.1111/j.1365-2036.2009.04203.x. Epub 2009 Nov 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 29, 2017)
12
Original Estimated Enrollment  ICMJE
 (submitted: June 26, 2007)
15
Actual Study Completion Date  ICMJE December 2008
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00492622
Other Study ID Numbers  ICMJE 014.07
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Louisville
Study Sponsor  ICMJE University of Louisville
Collaborators  ICMJE Bausch Health Americas, Inc.
Investigators  ICMJE
Principal Investigator: John M Wo, MD University of Louisville
PRS Account University of Louisville
Verification Date June 2017

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