Comparison of the Gastric Acid Suppressive Effects of Esomeprazole and Generic Omeprazole

NCT ID: NCT00542347

Last Updated: 2018-07-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2018-07-31

Brief Summary

Proton pump inhibitors (PPI) are used to decrease stomach acid secretion. A generic form of omeprazole, one of the PPIs, is on the market. With cheaper than brand name PPIs, it is unclear whether generic omeprazole is as effective clinically. This study compares generic omeprazole with half-dose esomeprazole, the strongest brand name PPI. The half-dose esomeprazole is in fact cheaper than generic omeprazole. Healthy volunteers will take each medication in turn for 7 days and their stomach acid will be measured while taking each medication. We hypothesize that half-dose esomeprazole is better at suppressing stomach acid than generic omeprazole.

Conditions

Gastric Acid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

• esomeprazole 20mg po once per day for 7 days
• 24hr pH study on day 7
• followed by washout for 7 days
• generic omeprazole 20mg po once per day for 7 days
• 24hr pH study on day 7

Group Type: ACTIVE_COMPARATOR

Esomeprazole first

Intervention Type: DRUG

• esomeprazole 20mg po once per day for 7 days
• 24hr pH study on day 7
• followed by washout for 7 days
• generic omeprazole 20mg po once per day for 7 days
• 24hr pH study on day 7

2

• generic omeprazole 20mg po once per day for 7 days
• 24hr pH study on day 7
• followed by washout for 7 days
• esomeprazole 20mg po once per day for 7 days
• 24hr pH study on day 7

Group Type: ACTIVE_COMPARATOR

Generic omeprazole first

Intervention Type: DRUG

• generic omeprazole 20mg po once per day for 7 days
• 24hr pH study on day 7
• followed by washout for 7 days
• esomeprazole 20mg po once per day for 7 days
• 24hr pH study on day 7

Interventions

Esomeprazole first

• esomeprazole 20mg po once per day for 7 days
• 24hr pH study on day 7
• followed by washout for 7 days
• generic omeprazole 20mg po once per day for 7 days
• 24hr pH study on day 7

Intervention Type: DRUG

Generic omeprazole first

• generic omeprazole 20mg po once per day for 7 days
• 24hr pH study on day 7
• followed by washout for 7 days
• esomeprazole 20mg po once per day for 7 days
• 24hr pH study on day 7

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• healthy, non-smoking volunteers older than 18 years of age

Exclusion Criteria

• history of gastrointestinal disease
• known infection
• previous eradication of Helicobacter pylori
• any prescription or over the counter antacid medication
• pregnant and lactating women

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Adriana Lazarescu

GI Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William G Paterson, MD

Role: PRINCIPAL_INVESTIGATOR

Queen's University, Hotel Dieu Hospital

Adriana Lazarescu, MD

Role: PRINCIPAL_INVESTIGATOR

Hotel Dieu Hospital

Locations

Hotel Dieu Hospital

Kingston, Ontario, Canada

Countries

Canada

Other Identifiers

1054-07

Identifier Type: -

Identifier Source: org_study_id