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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: NSAID Associated Gastric Ulcers

Treatments: Drug: Esomeprazole; Drug: Ranitidine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00633412

D9617C00005

SH-NEN-0005

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 3 patient groups

1

Experimental group

Description:

20mg Oral tablet daily

Treatment:

Drug: Esomeprazole

Drug: Esomeprazole

2

Experimental group

Description:

40mg Oral tablet daily

Treatment:

Drug: Esomeprazole

Drug: Esomeprazole

3

Active Comparator group

Description:

150mg oral twice daily

Treatment:

Drug: Ranitidine