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

This study has been completed.
Sponsor:
Collaborator:
Salix Pharmaceuticals
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00765206
First received: September 30, 2008
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Gastric Acid
Human Experimentation
Drug: Omeprazole/sodium bicarbonate
Drug: omeprazole magnesium (20 mg equivalent)
Phase 3

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® Tablets (20 Mg-equivalent Omeprazole)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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. 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: May 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zegerid
Omeprazole 20 mg /sodium bicarbonate 1100 mg over-the-counter (OTC) Capsule
Drug: Omeprazole/sodium bicarbonate
Single dose of omeprazole/sodium bicarbonate per day for either 1 or 7 days.
Other Name: Zegerid
Active Comparator: Prilosec
Omeprazole magnesium 20 mg OTC tablet
Drug: omeprazole magnesium (20 mg equivalent)
Single dose of omeprazole magnesium per day for either 1 or 7 days.
Other Name: Prilosec OTC Tablet

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.

  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: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00765206     History of Changes
Other Study ID Numbers: P07814, CL2008-02
Study First Received: September 30, 2008
Results First Received: August 28, 2009
Last Updated: October 28, 2013
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 April 15, 2014