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

Open-label randomized crossover design studies. 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. The other 30 participants will receive a single administration of sodium bicarbonate.

Study Type: Interventional

Study Design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Study Primary Completion Date: June 2008

Enrolled participants were divided into 2 groups, with 30 participants in each group.

Group 1: This group was randomized into a 2-way crossover design with an added third period. These participants received single administrations (day 1 dosing only) of Zegerid Powder for Oral Suspension, and Prilosec OTC (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.

Following completion of the 2-way crossover study, and a subsequent washout period (minimum of 2 weeks), all participants then received a single administration of sodium bicarbonate (at same dose as contained in Zegerid Powder for Oral Suspension) in Period 3. This group underwent a 24-hour intragastric pH study on each of the 3 dosing occasions.

Group 2: This group was randomized into a 2-way crossover design in which they received 7 days administration of Zegerid Powder for Oral Suspension 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 also underwent 24-hour intragastric pH recordings on the days on 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 and Zegerid Powder for Oral Suspension 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
  • Omeprazole/sodium bicarbonate. Single dose per day for either 1 or 7 days.
• Drug: omeprazole magnesium
  • Omeprazole 20 mg tablet. Single dose per day for either 1 or 7 days.
• Drug: sodium bicarbonate
  • Sodium bicarbonate. Single dose.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Single Dose Zegerid for 1 or 7 days
  • Omeprazole 20 mg/Sodium Bicarbonate 1680 mg Powder for Oral Suspension
• Active Comparator: Single Dose Prilosec 1 or 7 days
  • Omeprazole magnesium 20 mg over-the-counter (OTC) Tablet
• Active Comparator: Sodium Bicarbonate
  • Sodium Bicarbonate 1680 mg Oral Suspension

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 Sponsor: Schering-Plough

Information obtained from ClinicalTrials.gov on September 07, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00674115

Study ID Number: CL2007-17

ClinicalTrials.gov Identifier: NCT00674115

Health Authority: United States: Food and Drug Administration