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 subjects will be evaluated on Day 1 to compare effects on stomach acid; 30 subjects will continue treatment for 7 days and will have repeat evaluations at Day 7.

Study Type: Interventional

Study Design: Other, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacodynamics Study

Study Primary Completion Date: August 2008

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: 1
  • Omeprazole /sodium bicarbonate.
• Active Comparator: 2
  • omeprazole magnesium

Primary Measures

• The primary outcome measure is the change from baseline in median 24-hr intragastric pH for Zegerid and delayed-release omeprazole on the 7th day of drug administration.
  • Time Frame: For single dose group- the 24 hours after dosing. For 7 day treatment group- the 24 hours after 1st and last doses.
    Safety Issue?: No

Secondary Measures

• Changes from baseline in median 24-hr intragastric pH on the 1st day of drug administration.
  • Time Frame: For single dose group- 24 hours after dosing. For 7 day treatment group- the 24 hours after 1st and last doses.
    Safety Issue?: No
• Changes from baseline of mean gastric acid concentration over 24-hrs on the 1st and 7th days of treatment.
  • Time Frame: For single dose group- 24 hours after dosing. For 7 day treatment group- the 24 hours after 1st and last doses.
    Safety Issue?: No
• Time to onset of inhibition of acid secretion on the first day of treatment. 1.
  • Time Frame: For single dose group- 24 hours after dosing. For 7 day treatment group- the 24 hours after 1st and last doses.
    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 GI disease
• Any significant medical illness
• Gastrointestinal disorder or surgery leading to impaired drug absorption
• Currently using GI 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 July 02, 2009

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