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

Sponsors and Collaborators:	Schering-Plough Santarus
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00674115

Purpose

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.

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

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Crossover Assignment, Pharmacodynamics Study
Official Title:	Randomized, Crossover Pharmacodynamic Study Comparing the Effects of Zegerid® (20 mg Omeprazole/Sodium Bicarbonate) and Prilosec OTC® (20 mg-Equivalent Omeprazole)

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

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 ]

Secondary Outcome 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. ] [ 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 ]

Estimated 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
Single Dose Zegerid for 1 or 7 days: Experimental Omeprazole /sodium bicarbonate	Drug: Omeprazole/sodium bicarbonate Omeprazole/sodium bicarbonate. Single dose per day for either 1 or 7 days.
Single Dose Prilosec OTC Tablet for 1 or 7 days: Active Comparator omeprazole magnesium	Drug: omeprazole magnesium Omeprazole 20 mg tablet. Single dose per day for either 1 or 7 days.
sodium bicarbonate: Active Comparator Sodium bicarbonate	Drug: sodium bicarbonate Sodium bicarbonate. Single 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 GI disease
Any significant medical illness
Gastrointestinal disorder or surgery leading to impaired drug absorption
Currently using GI medications

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	CL2007-17
Study First Received:	May 2, 2008
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00674115 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Omeprazole

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents

Omeprazole
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009