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

NCT00542347 | Terminated Phase 3

• 1 other identifier: 1054-07
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

gastric acid; proton pump inhibitors; omeprazole; esomeprazole

Outcome Measures

Primary Outcomes (1)

• Median intragastric pH and percentage of time that intragastric pH is above 4

  24 hours

Secondary Outcomes (1)

• Nocturnal acid breakthrough, defined as at least 60 continuous minutes of intragastric pH below 4 occurring between 10pm and 6 am and adverse events

  24 hours

Study Arms (2)

1

ACTIVE COMPARATOR

* 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

Drug: Esomeprazole first

2

ACTIVE COMPARATOR

* 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

Drug: Generic omeprazole first

Interventions

Esomeprazole first 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

1

Generic omeprazole first 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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Queen's University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Hotel Dieu Hospital

Kingston, Ontario, K7L 5G2, Canada

Location

Study Officials

• William G Paterson, MD

  Queen's University, Hotel Dieu Hospital

  PRINCIPAL INVESTIGATOR

• Adriana Lazarescu, MD

  Hotel Dieu Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: GI Fellow

Study Record Dates

• First Submitted: October 9, 2007
• First Posted: October 11, 2007
• Study Start: September 1, 2007
• Primary Completion: April 1, 2017
• Study Completion: July 1, 2018
• Last Updated: July 20, 2018

Record last verified: 2018-07

Locations

CA (1)