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

AstraZeneca400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

400

Conditions

NSAID Associated Gastric Ulcers

Interventions

EsomeprazoleDRUG

20mg oral daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

The proportion of patients with no gastric ulcers after 8 weeks of treatment.

Time frame: 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 Outcomes

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

Time frame: 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.

Time frame: Assessments at Week 0, Week 4 and Week 8