A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine 150mg Bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is Continued in Subjects in the US Only

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00633412

Enrollment

400

Registered

2008-03-12

Start date

2001-02-28

Completion date

2003-03-31

Last updated

2009-06-11

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 treatment of these gastric ulcers with one of the three following treatment groups for up to 8 weeks: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine 150 mg twice daily for subjects in the US only.

Interventions

DRUGEsomeprazole

20mg oral daily

DRUGRanitidine

150mg oral twice daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* A clinical diagnosis of a chronic condition (eg osteoarthritis or rheumatoid arthritis) that requires daily NSAID treatment for at least 2 months. * A gastric ulcer \>= 5mm in diameter, but no ulcer \>25 mm at its greatest diameter, at the baseline endoscopy. * Other key inclusion criteria, as specified in the protocol.

Exclusion criteria

* History of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer. * History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis. * Many other conditions and criteria, as specified in the protocol.

Design outcomes

Primary

Measure	Time frame
The proportion of patients with no gastric ulcers after 8 weeks of treatment.	Esophagogastroduodenscopy (EGD) assessments at baseline, week 4, week 8, and efficacy evaluations at each visit including endoscopic evaluation for the presence of ulcers and erosions.

Secondary

Measure	Time frame
The patient and investigator symptoms, defined as control of NSAID-associated GI symptoms up to 8 weeks of treatment with esomeprazole 40 mg vs ranitidine 150 mg bid and esomeprazole 20 mg qd versus ranitidine 150 mg bid in patients receiving daily N	Assessments at Week 0, Week 4 and Week 8
To look at any side effects of esomeprazole 40 mg vs ranitidine 150 mg bid and esomeprazole 20 mg qd versus ranitidine 150 mg bid in patients receiving daily NSAID therapy.	Assessments at Week 0, Week 4 and Week 8

Outcome results

None listed

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