Ulcer Prevention II

A Comparative Efficacy and Safety of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Placebo for the Prevention of Gastric and Duodenal Ulcers Associated With Daily NSAID Use in Patients at Risk

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00629928

Enrollment

800

Registered

2008-03-06

Start date

2001-02-28

Completion date

2003-03-31

Last updated

2011-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NSAID Associated Gastric Ulcers

Keywords

NSAID, Nexium, esomeprazole, Gastric Ulcers

Brief summary

Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the prevention of these gastric ulcers, in patients deemed to be at risk, with either esomeprazole 40 mg once daily; esomeprazole 20 mg once daily.

Interventions

DRUGEsomeprazole

20mg oral capsule daily

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

1. No active/current gastric or duodenal ulcer on baseline endoscopy. 2. A clinical diagnosis of a chronic condition that requires daily NSAID treatment for at least 6 months. 3. Other inclusion criteria, as defined in the protocol.

Exclusion criteria

1\. History of esophageal, gastric or duodenal surgery, except the simple closure of an ulcer. * 2\. History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis. * 3\. Other criteria, as defined in the protocol.

Design outcomes

Primary

Measure	Time frame
To assess the efficacy of esomeprazole 40 mg qd versus placebo and esomeprazole 20 mg qd versus placebo for up to 6 months of treatment for the prevention of gastric (and duodenal) ulcers in patients receiving daily NSAID therapy.	Assessments at Week 0, Week 4, Week 12, Week 26

Secondary

Measure	Time frame
Investigator assessed symptoms, defined as control of NSAID-associated GI symptoms for up to 6 months of treatment with esomeprazole 40 mg qd versus placebo and esomeprazole 20 mg qd versus placebo in patients receiving daily NSAID therapy.	Assessments at Week 0, Week 4, Week 12, Week 26
Safety and tolerability of esomeprazole 40 mg qd versus placebo and esomeprazole 20 mg qd versus placebo when administered for up to 6 months to patients receiving daily NSAID therapy.	Assessments at Week 0, Week 4, Week 12, Week 26

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026