A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(COMPLETED) - Full Text View

Sponsor:	Schering-Plough
Collaborator:	Santarus
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00674115

Purpose

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.

Condition	Intervention	Phase
Gastric Acid Human Experimentation	Drug: Omeprazole/sodium bicarbonate Drug: omeprazole magnesium Drug: sodium bicarbonate	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Open Label
Official Title:	Randomized, Crossover Pharmacodynamic Study Comparing the Effects of Zegerid® (20 mg Omeprazole/Sodium Bicarbonate) and Prilosec OTC® (20 Mg-equivalent Omeprazole)

Resource links provided by NLM:

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium Sodium bicarbonate Magnesium

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

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. PH measures how acidic or basic a substance is. 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.

Enrollment:	60
Study Start Date:	April 2008
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Single Dose Zegerid for 1 or 7 days Omeprazole 20 mg/Sodium Bicarbonate 1680 mg Powder for Oral Suspension	Drug: Omeprazole/sodium bicarbonate Omeprazole/sodium bicarbonate. Single dose per day for either 1 or 7 days. Other Name: Zegerid
Active Comparator: Single Dose Prilosec 1 or 7 days Omeprazole magnesium 20 mg over-the-counter (OTC) Tablet	Drug: omeprazole magnesium Omeprazole 20 mg tablet. Single dose per day for either 1 or 7 days. Other Name: Prilosec OTC Tablet
Active Comparator: Sodium Bicarbonate Sodium Bicarbonate 1680 mg Oral Suspension	Drug: sodium bicarbonate Sodium bicarbonate. Single dose.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00674115 History of Changes
Other Study ID Numbers:	CL2007-17
Study First Received:	May 2, 2008
Results First Received:	September 17, 2009
Last Updated:	April 8, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Omeprazole
Omeprazole, sodium bicarbonate drug combination
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Proton Pump Inhibitors

ClinicalTrials.gov processed this record on February 12, 2012