Ignite Creation Date:
2024-05-05 @ 10:17 PM
Last Modification Date:
2024-10-26 @ 10:16 AM
Study NCT ID:
NCT01077076
Status:
COMPLETED
Last Update Posted:
2015-03-11
First Post:
2010-02-25
Brief Title:
Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole P07812 COMPLETED
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Randomized Placebo-Controlled Crossover Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole
Status:
COMPLETED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized crossover study is to evaluate the early effectiveness defined as effect on intragastric pH during the first 4 hours after dosing of Zegerid Prilosec over-the-counter OTC Tablets and placebo on the 4th day of treatment to inhibit acid secretion Additional purposes are to
1 provide pharmacodynamic evidence comparing 24-hr inhibition of acid secretion on the 1st 4th and 11th days of dosing with each of the indicated treatments
2 compare Zegerid and Prilosec OTC for achieving their steady-state effects for controlling 24-hr gastric acidity at steady-state on the 4th and 11th day of dosing
3 evaluate early effectiveness defined as effect on intragastric pH during the first 4 hours after administration of Zegerid Prilosec OTC Tablets and placebo on acid inhibition at steady-state when administered on the 11th day of dosing
1 provide pharmacodynamic evidence comparing 24-hr inhibition of acid secretion on the 1st 4th and 11th days of dosing with each of the indicated treatments
2 compare Zegerid and Prilosec OTC for achieving their steady-state effects for controlling 24-hr gastric acidity at steady-state on the 4th and 11th day of dosing
3 evaluate early effectiveness defined as effect on intragastric pH during the first 4 hours after administration of Zegerid Prilosec OTC Tablets and placebo on acid inhibition at steady-state when administered on the 11th day of dosing
Detailed Description:
Participants were randomized in a 3-way crossover design and received in random order Zegerid OTC Capsules 20 mg omeprazole and 1100 mg sodium bicarbonate Prilosec OTC Tablets 20 mg-equivalent omeprazole and Placebo Capsules Participants received each treatment for 11 days There was a minimum of a 2-week washout period between treatment arms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P07812 | OTHER | Merck | None |