Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Gastroparesis
NCT ID: NCT00492622
Last Updated: 2017-07-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
12 participants
INTERVENTIONAL
2007-06-30
2008-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill
NCT00045799
A Study to Investigate the Relative Bioavailability of 2 Different Formulations of AZD4144, the Effect of Food and Omeprazole on the Pharmacokinetics of AZD4144 in Healthy Participants
NCT06948006
An Open, Randomized, Two Way Crossover Study Comparing the Effect of 20mg Esomeprazole Administered Orally and Intravenously as a 15 Minute Infusion on Basal and Pentagastrin-Stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD)
NCT00629564
A Study to Examine the Effect of Omeprazole, Famotidine, and an Acidic Beverage on the Pharmacokinetics of Entinostat in Healthy Adult Subjects
NCT02922933
BE of Torrent's Esomeprazole Mg DR Capsules
NCT02680119
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Immediate-release omeprazole release first
subjects receive immediate release omeprazole for 7 days then delayed release for 7 days
Immediate-release omeprazole
Immediate-release omeprazole 40 mg qam for 7 days
Delayed-release omeprazole
Delayed-release omeprazole 40 mg qam for 7 days
Delayed-release omeprazole first
subjects receive delayed release omeprazole for 7 days then immediate release for 7 days
Immediate-release omeprazole
Immediate-release omeprazole 40 mg qam for 7 days
Delayed-release omeprazole
Delayed-release omeprazole 40 mg qam for 7 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Immediate-release omeprazole
Immediate-release omeprazole 40 mg qam for 7 days
Delayed-release omeprazole
Delayed-release omeprazole 40 mg qam for 7 days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bausch Health Americas, Inc.
INDUSTRY
University of Louisville
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
John M Wo, MD
Role: PRINCIPAL_INVESTIGATOR
University of Louisville
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Digestive Health Center, University of Louisville Hospital
Louisville, Kentucky, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
014.07
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.