A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (Study CL2008-02)(COMPLETED)

Official Title: “Randomized, Crossover Pharmacodynamic Study Comparing the Effects of Zegerid® (20 mg Omeprazole/Sodium Bicarbonate) and Prilosec OTC® Tablets (20 Mg-equivalent Omeprazole)”

Open-label randomized crossover design study. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7.

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.

Intervention(s) in this Clinical Trial

• Drug: Omeprazole/sodium bicarbonate
  • Single dose of omeprazole/sodium bicarbonate per day for either 1 or 7 days.
• Drug: omeprazole magnesium (20 mg equivalent)
  • Single dose of omeprazole magnesium per day for either 1 or 7 days.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Zegerid
  • Omeprazole 20 mg /sodium bicarbonate 1100 mg over-the-counter (OTC) Capsule
• Active Comparator: Prilosec
  • Omeprazole magnesium 20 mg OTC tablet

Primary Measures

• Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration
  • Time Frame: Baseline and 7 days
    Safety Issue?: No

Inclusion Criteria:

• Normal subjects who are 18-65 years of age.
• Non-childbearing potential females or those using birth control.

Exclusion Criteria:

• History of hypersensitivity, allergy or intolerance to omeprazole or other proton pump inhibitors
• History of significant gastrointestinal disease
• Any significant medical illness
• Gastrointestinal disorder or surgery leading to impaired drug absorption
• Currently using gastrointestinal medications

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Schering-Plough Industry

Information obtained from ClinicalTrials.gov on February 08, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00765206

Study ID Number: CL2008-02

ClinicalTrials.gov Identifier: NCT00765206

Health Authority: United States: Food and Drug Administration