A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (COMPLETED) - Tabular View

Tracking Information
First Received Date ^ICMJE	May 2, 2008
Last Updated Date	September 3, 2008
Start Date ^ICMJE	April 2008
Primary Completion Date	June 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 2, 2008)	The primary outcome measure is the change from baseline in median 24-hr intragastric pH for Zegerid and Prilosec OTC on the 7th day of drug administration. [ Time Frame: For single dose group- the 24 hours after dosing. ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00674115 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 2, 2008)	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. ] [ Designated as 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. ] [ Designated as safety issue: No ] Time to onset of inhibition of acid secretion on the first day of treatment. [ Time Frame: For single dose group- 24 hours after dosing. ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (COMPLETED)
Official Title ^ICMJE	Randomized, Crossover Pharmacodynamic Study Comparing the Effects of Zegerid® (20 mg Omeprazole/Sodium Bicarbonate) and Prilosec OTC® (20 mg-Equivalent Omeprazole)
Brief Summary	Open-label randomized crossover design studies. 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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Other, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacodynamics Study
Condition ^ICMJE	Gastric Acid Human Experimentation
Intervention ^ICMJE	Drug: Omeprazole/sodium bicarbonate Drug: omeprazole magnesium Drug: sodium bicarbonate
Study Arms / Comparison Groups	Experimental: Omeprazole /sodium bicarbonate Active Comparator: omeprazole magnesium Active Comparator: Sodium bicarbonate
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	60
Completion Date	June 2008
Primary Completion Date	June 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00674115
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Study ID Numbers ^ICMJE	CL2007-17
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE	Santarus
Investigators ^ICMJE
Information Provided By	Schering-Plough
Verification Date	September 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP