A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (Study CL2008-02)(P07814)(COMPLETED)
|Gastric Acid Human Experimentation||Drug: Omeprazole/sodium bicarbonate Drug: omeprazole magnesium (20 mg equivalent)||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
|Official Title:||Randomized, Crossover Pharmacodynamic Study Comparing the Effects of Zegerid® (20 mg Omeprazole/Sodium Bicarbonate) and Prilosec OTC® Tablets (20 Mg-equivalent Omeprazole)|
- Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration [ Time Frame: Baseline and 7 days ]The change from Baseline in median pH was calculated as: median pH on Day 7 minus median pH at Baseline. The pH scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic. A pH greater than 7 is basic.
|Study Start Date:||May 2008|
|Study Completion Date:||August 2008|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
Omeprazole 20 mg /sodium bicarbonate 1100 mg over-the-counter (OTC) Capsule
Drug: Omeprazole/sodium bicarbonate
Single dose of omeprazole/sodium bicarbonate per day for either 1 or 7 days.
Other Name: Zegerid
Active Comparator: Prilosec
Omeprazole magnesium 20 mg OTC tablet
Drug: omeprazole magnesium (20 mg equivalent)
Single dose of omeprazole magnesium per day for either 1 or 7 days.
Other Name: Prilosec OTC Tablet
Enrolled participants were divided into 2 groups, with 30 participants in each group.
Group 1: This group was randomized into a single-dose, 2-way crossover design. These participants received single administrations (day 1 dosing only) of Zegerid OTC Capsules, and Prilosec OTC Tablets (both at a 20 mg omeprazole dose), in a 2-way randomized order, with a minimum of a 2-week washout period between treatment legs. This group underwent a 24-hour intragastric pH study on each of the 2 dosing occasions.
Group 2: This group was randomized into a 2-way crossover design in which they received 7 days administration of Zegerid OTC Capsules and Prilosec OTC Tablets, respectively. As with the prior group, there was a minimum of a 2-week washout period between treatment legs. Participants assigned to this treatment group underwent 24-hour intragastric pH recordings on the days which they received their 1st and last (7th) dose of the two treatment drugs.
In addition to the above detailed procedures, all participants (both groups) underwent a 24-hour baseline intragastric pH study prior to starting their randomized treatments. This study design enabled all 60 participants to be evaluated for effects of the first dose of Prilosec OTC Tablets and Zegerid OTC Capsules on change in intragastric pH during the subsequent 24-hour period following the first dose.