CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 12 enrolled
Drug / intervention
Immediate-release omeprazole +1 moredrug
Likely dose
Immediate-release omeprazole 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00492622
NCT00492622Phase 4Completed

Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Patients With Heartburn Associated With Gastroparesis

University of Louisville·interventional·Posted Jun 27, 2007·Updated Jul 28, 2017

In Brief

A Phase 4 clinical trial evaluating Immediate-release omeprazole and Delayed-release omeprazole for Gastroparesis and Gastroesophageal Reflux Disease. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 27, 2007
Enrollment StartJun 1, 2007
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 19.0 years ago

Interventions

Immediate-release omeprazoledrug

Immediate-release omeprazole 40 mg qam for 7 days

Delayed-release omeprazoledrug

Delayed-release omeprazole 40 mg qam for 7 days