A Phase 4 interventional study of Immediate-release omeprazole and Delayed-release omeprazole in Gastroparesis and Gastroesophageal Reflux Disease, sponsored by University of Louisville. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-07-28.
Sponsored by University of Louisville · Phase 4, Interventional, and Treatment
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.
1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's enrollment of 12 is below the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →University of Louisville is the lead sponsor of 284 studies on the registry; 53 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 7 (35%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
subjects receive immediate release omeprazole for 7 days then delayed release for 7 days
Drug: Immediate-release omeprazole · Drug: Delayed-release omeprazole
subjects receive delayed release omeprazole for 7 days then immediate release for 7 days
Drug: Immediate-release omeprazole · Drug: Delayed-release omeprazole
Immediate-release omeprazole 40 mg qam for 7 days
Delayed-release omeprazole 40 mg qam for 7 days
Time to Maximal Omeprazole Concentration (Tmax)
Time to max concentration for Immediate release vs. Delayed release omeprazole
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 Omerazole
Maximal concentration of immediate-release vs. delayed-release omeprazole
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
Area Under the Curve for Omeprazole Plasma Concentration
The area under the curve for omeprazole concentration-time curve for immediate release and delayed release omeprazole.
Time frame: 0 to 5 hrs after the study drug was ingested on treatment day 7
| Milestone | All Study Participants |
|---|---|
| Started | 12 |
| Completed | 12 |
| Not completed | 0 |
Time to max concentration for Immediate release vs. Delayed release omeprazole
| minutes | All Study Participants Immediate Release Arm | All Study Subjects Delayed Release Arm |
|---|---|---|
| Time to Maximal Omeprazole Concentration (Tmax) | 32 ± 11 | 97 ± 46 |
Maximal concentration of immediate-release vs. delayed-release omeprazole
| ng/mL plasma | All Study Participants Immediate Release Arm | All Study Subjects Delayed Release Arm |
|---|---|---|
| Maximal Concentration of Omerazole | 1979 ± 832 | 1625 ± 921 |
The area under the curve for omeprazole concentration-time curve for immediate release and delayed release omeprazole.
| mg*h/mL | All Study Participants Immediate Release Arm | All Study Subjects Delayed Release Arm |
|---|---|---|
| Area Under the Curve for Omeprazole Plasma Concentration | 3842 ± 1618 | 3745 ± 2386 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Immediate Release Fomeprazole | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Delayed Release Omeprazole | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Age, Continuous(years) | All Participants |
|---|---|
| Mean | 51 ± 10 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 12 |
| Male | 0 |
| Region of Enrollment(Participants) | All Participants |
|---|---|
| United States | 12 |
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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University of Louisville