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| Name | Class |
|---|---|
| Bausch Health Americas, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate-release omeprazole release first | Experimental | subjects receive immediate release omeprazole for 7 days then delayed release for 7 days |
|
| Delayed-release omeprazole first | Experimental | subjects receive delayed release omeprazole for 7 days then immediate release for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate-release omeprazole | Drug | Immediate-release omeprazole 40 mg qam for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Maximal Omeprazole Concentration (Tmax) | Time to max concentration for Immediate release vs. Delayed release omeprazole | 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 | 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. | 0 to 5 hrs after the study drug was ingested on treatment day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John M Wo, MD | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Digestive Health Center, University of Louisville Hospital | Louisville | Kentucky | 40202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19925497 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | All participants were randomized to receive all formulations so baseline measures are reported for all participants. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Maximal Omeprazole Concentration (Tmax) | Time to max concentration for Immediate release vs. Delayed release omeprazole | All subjects were included regardless of which formulation they received first. | Posted | Mean | Standard Deviation | minutes | 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 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immediate Release Fomeprazole | subjects received immediate release for 7 days then delayed release for 7 days Immediate-release omeprazole: Immediate-release omeprazole 40 mg qam for 7 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy Alsip | University Louisville | 502-852-2905 | nancy.alsip@louisville.edu |
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| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| D005764 | Gastroesophageal Reflux |
| D006356 | Heartburn |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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| Delayed-release omeprazole | Drug | Delayed-release omeprazole 40 mg qam for 7 days |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| Primary | Maximal Concentration of Omerazole | Maximal concentration of immediate-release vs. delayed-release omeprazole | All subjects were included, regardless of which formulation they received first. | Posted | Mean | Standard Deviation | ng/mL plasma | 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 |
|
|
|
|
| Primary | 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. | the AUC for each formulation were combined regardless of order given | Posted | Mean | Standard Deviation | mg*h/mL | 0 to 5 hrs after the study drug was ingested on treatment day 7 |
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|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Delayed Release Omeprazole | subjects receive delayed release for 7 days then immediate release for 7 days Delayed-release omeprazole: Delayed-release omeprazole 40 mg qam for 7 days | 0 | 12 | 0 | 12 | 0 | 12 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D012817 | Signs and Symptoms, Digestive |