A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED)

Human Experimentation Clinical Trial

Official title:

Randomized, Crossover Pharmacodynamic Study Comparing the Effects of Zegerid® (20 mg Omeprazole/Sodium Bicarbonate) and Prilosec OTC® (20 Mg-equivalent Omeprazole)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00674115
• Other study ID #: 18133
• Secondary ID: CL2007-17P07813
• Status: Completed
• Phase: Phase 3
• First received: May 2, 2008
• Last updated: February 20, 2015
• Start date: April 2008
• Est. completion date: June 2008

Study information

• Verified date: February 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Gastric Acid
• Human Experimentation

Intervention

Drug:
• Omeprazole/sodium bicarbonate
Omeprazole/sodium bicarbonate. Single dose per day for either 1 or 7 days.
• omeprazole magnesium
Omeprazole 20 mg tablet. Single dose per day for either 1 or 7 days.
• sodium bicarbonate
Sodium bicarbonate. Single dose.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Valeant Pharmaceuticals International, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration	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.	Baseline and 7 days	No