A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (Study CL2008-02)(P07814)(COMPLETED)

This study has been completed.

Sponsor:

Collaborator:

Santarus

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00765206

First received: September 30, 2008

Last updated: February 27, 2013

Last verified: February 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	September 30, 2008
Last Updated Date	February 27, 2013
Start Date ^ICMJE	May 2008
Primary Completion Date	August 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 8, 2010)	Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration [ Time Frame: Baseline and 7 days ] [ Designated as safety issue: No ] 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.
Original Primary Outcome Measures ^ICMJE (submitted: September 30, 2008)	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. ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00765206 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE (submitted: September 30, 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. For 7 day treatment group- the 24 hours after 1st and last doses. ] [ 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. For 7 day treatment group- the 24 hours after 1st and last doses. ] [ Designated as 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. ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (Study CL2008-02)(P07814)(COMPLETED)
Official Title ^ICMJE	Randomized, Crossover Pharmacodynamic Study Comparing the Effects of Zegerid® (20 mg Omeprazole/Sodium Bicarbonate) and Prilosec OTC® Tablets (20 Mg-equivalent Omeprazole)
Brief Summary	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.
Detailed Description	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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Open Label
Condition ^ICMJE	Gastric Acid Human Experimentation
Intervention ^ICMJE	Drug: Omeprazole/sodium bicarbonate Single dose of omeprazole/sodium bicarbonate per day for either 1 or 7 days. Other Name: Zegerid Drug: omeprazole magnesium (20 mg equivalent) Single dose of omeprazole magnesium per day for either 1 or 7 days. Other Name: Prilosec OTC Tablet
Study Arm (s)	Experimental: Zegerid Omeprazole 20 mg /sodium bicarbonate 1100 mg over-the-counter (OTC) Capsule Intervention: Drug: Omeprazole/sodium bicarbonate Active Comparator: Prilosec Omeprazole magnesium 20 mg OTC tablet Intervention: Drug: omeprazole magnesium (20 mg equivalent)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	60
Completion Date	August 2008
Primary Completion Date	August 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 gastrointestinal disease Any significant medical illness Gastrointestinal disorder or surgery leading to impaired drug absorption Currently using gastrointestinal 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	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00765206
Other Study ID Numbers ^ICMJE	CL2008-02
Has Data Monitoring Committee	No
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Santarus
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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