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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00492622
First Posted: June 27, 2007
Last Update Posted: July 28, 2017
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.
Collaborator:
Valeant Pharmaceuticals International, Inc.
Information provided by (Responsible Party):
University of Louisville
  Purpose
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.

Condition Intervention Phase
Gastroparesis Gastroesophageal Reflux Disease Drug: Immediate-release omeprazole Drug: Delayed-release omeprazole Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Patients With Heartburn Associated With Gastroparesis

Resource links provided by NLM:


Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • 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.


Enrollment: 12
Study Start Date: June 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00492622


Locations
United States, Kentucky
Digestive Health Center, University of Louisville Hospital
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Valeant Pharmaceuticals International, Inc.
Investigators
Principal Investigator: John M Wo, MD University of Louisville
  More Information

Publications:
Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT00492622     History of Changes
Other Study ID Numbers: 014.07
First Submitted: June 26, 2007
First Posted: June 27, 2007
Results First Submitted: April 6, 2017
Results First Posted: July 28, 2017
Last Update Posted: July 28, 2017
Last Verified: June 2017

Keywords provided by University of Louisville:
Gastroparesis
Gastroesophageal reflux disease
heartburn

Additional relevant MeSH terms:
Gastroesophageal Reflux
Gastroparesis
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action


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